{"meta":{"dataset":"device-events","title":"Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA)","version":"1.0.0","doi":"10.5281/zenodo.23752988","doiUrl":"https://doi.org/10.5281/zenodo.23752988","conceptDoi":"10.5281/zenodo.23752987","license":"CC BY 4.0","licenseUrl":"https://creativecommons.org/licenses/by/4.0/","attribution":"Source: Probative, Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA), version 1.0.0, https://doi.org/10.5281/zenodo.23752988, licensed CC BY 4.0.","citation":"Probative. (2026). Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA) (Version 1.0.0) [Data set]. Zenodo. https://doi.org/10.5281/zenodo.23752988","disclaimer":"Not legal advice. A report to the FDA is an allegation that a device may have caused or contributed to an event, not a finding that it did, and a count of reports is not an incidence rate or proof of a defect. Questions about an injury from a medical device are for a licensed product-liability attorney and the person's doctor.","notice":"Probative is a marketing firm, not a law firm; not legal advice.","lastChecked":"2026-10-29","url":"https://probativegrowth.com/data/v1/device-events/device-events.json","humanUrl":"https://probativegrowth.com/data/device-events/","statusCodes":{"P":"primary source","S":"secondary source","D":"ABA model default","U":"open question"}},"key":"quarter","records":[{"id":"device-events:US:2026Q3","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"All medical devices, 2026 Q3: 1,189,467 adverse event reports received by the FDA (2,774 death, 326,637 injury, 857,230 malfunction and 2,826 other). Recent quarter: reports are still arriving.","value":1189467,"unit":"device adverse event reports received","reports":1189467,"deaths":2774,"injuries":326637,"malfunctions":857230,"other":2826,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:US:2026Q2","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"All medical devices, 2026 Q2: 923,529 adverse event reports received by the FDA (3,477 death, 318,321 injury, 601,660 malfunction and 71 other).","value":923529,"unit":"device adverse event reports received","reports":923529,"deaths":3477,"injuries":318321,"malfunctions":601660,"other":71,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:US:2026Q1","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"All medical devices, 2026 Q1: 811,618 adverse event reports received by the FDA (4,022 death, 292,256 injury, 515,289 malfunction and 51 other).","value":811618,"unit":"device adverse event reports received","reports":811618,"deaths":4022,"injuries":292256,"malfunctions":515289,"other":51,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:US:2025Q4","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"All medical devices, 2025 Q4: 751,012 adverse event reports received by the FDA (3,147 death, 297,353 injury, 450,451 malfunction and 61 other).","value":751012,"unit":"device adverse event reports received","reports":751012,"deaths":3147,"injuries":297353,"malfunctions":450451,"other":61,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:US:2025Q3","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"All medical devices, 2025 Q3: 819,444 adverse event reports received by the FDA (3,204 death, 347,940 injury, 468,215 malfunction and 85 other).","value":819444,"unit":"device adverse event reports received","reports":819444,"deaths":3204,"injuries":347940,"malfunctions":468215,"other":85,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:US:2025Q2","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"All medical devices, 2025 Q2: 632,296 adverse event reports received by the FDA (3,371 death, 221,102 injury, 407,776 malfunction and 47 other).","value":632296,"unit":"device adverse event reports received","reports":632296,"deaths":3371,"injuries":221102,"malfunctions":407776,"other":47,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:US:2025Q1","dataset":"device-events","jurisdiction":"US","level":"us","productCode":null,"deviceName":"All device product codes","specialty":null,"deviceClass":null,"quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"All medical devices, 2025 Q1: 685,251 adverse event reports received by the FDA (3,564 death, 277,810 injury, 403,809 malfunction and 68 other).","value":685251,"unit":"device adverse event reports received","reports":685251,"deaths":3564,"injuries":277810,"malfunctions":403809,"other":68,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2026 Q3: 228,695 adverse event reports received by the FDA (30 death, 5,461 injury, 222,887 malfunction and 317 other). Recent quarter: reports are still arriving.","value":228695,"unit":"device adverse event reports received","reports":228695,"deaths":30,"injuries":5461,"malfunctions":222887,"other":317,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DZE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2026 Q3: 193,702 adverse event reports received by the FDA (1 death, 193,493 injury, 166 malfunction and 42 other). Recent quarter: reports are still arriving.","value":193702,"unit":"device adverse event reports received","reports":193702,"deaths":1,"injuries":193493,"malfunctions":166,"other":42,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QFG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2026 Q3: 114,688 adverse event reports received by the FDA (90 death, 15,433 injury, 99,080 malfunction and 85 other). Recent quarter: reports are still arriving.","value":114688,"unit":"device adverse event reports received","reports":114688,"deaths":90,"injuries":15433,"malfunctions":99080,"other":85,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QLG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2026 Q3: 104,362 adverse event reports received by the FDA (2 death, 783 injury, 103,562 malfunction and 15 other). Recent quarter: reports are still arriving.","value":104362,"unit":"device adverse event reports received","reports":104362,"deaths":2,"injuries":783,"malfunctions":103562,"other":15,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FPA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2026 Q3: 102,841 adverse event reports received by the FDA (61 death, 31,698 injury, 71,005 malfunction and 77 other). Recent quarter: reports are still arriving.","value":102841,"unit":"device adverse event reports received","reports":102841,"deaths":61,"injuries":31698,"malfunctions":71005,"other":77,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PZE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2026 Q3: 27,512 adverse event reports received by the FDA (0 death, 151 injury, 27,360 malfunction and 1 other). Recent quarter: reports are still arriving.","value":27512,"unit":"device adverse event reports received","reports":27512,"deaths":0,"injuries":151,"malfunctions":27360,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OZP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2026 Q3: 25,191 adverse event reports received by the FDA (12 death, 1,523 injury, 23,649 malfunction and 7 other). Recent quarter: reports are still arriving.","value":25191,"unit":"device adverse event reports received","reports":25191,"deaths":12,"injuries":1523,"malfunctions":23649,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:BRY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2026 Q3: 17,244 adverse event reports received by the FDA (1 death, 1 injury, 17,199 malfunction and 43 other). Recent quarter: reports are still arriving.","value":17244,"unit":"device adverse event reports received","reports":17244,"deaths":1,"injuries":1,"malfunctions":17199,"other":43,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OSR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2026 Q3: 15,267 adverse event reports received by the FDA (0 death, 10 injury, 15,252 malfunction and 5 other). Recent quarter: reports are still arriving.","value":15267,"unit":"device adverse event reports received","reports":15267,"deaths":0,"injuries":10,"malfunctions":15252,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:BZD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2026 Q3: 15,015 adverse event reports received by the FDA (1 death, 119 injury, 14,878 malfunction and 17 other). Recent quarter: reports are still arriving.","value":15015,"unit":"device adverse event reports received","reports":15015,"deaths":1,"injuries":119,"malfunctions":14878,"other":17,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FRN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pump, Infusion (product code FRN), 2026 Q3: 13,208 adverse event reports received by the FDA (10 death, 189 injury, 12,766 malfunction and 243 other). Recent quarter: reports are still arriving.","value":13208,"unit":"device adverse event reports received","reports":13208,"deaths":10,"injuries":189,"malfunctions":12766,"other":243,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ITJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Walker, Mechanical (product code ITJ), 2026 Q3: 10,831 adverse event reports received by the FDA (0 death, 60 injury, 10,721 malfunction and 50 other). Recent quarter: reports are still arriving.","value":10831,"unit":"device adverse event reports received","reports":10831,"deaths":0,"injuries":60,"malfunctions":10721,"other":50,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FDS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2026 Q3: 10,823 adverse event reports received by the FDA (1 death, 12 injury, 10,809 malfunction and 1 other). Recent quarter: reports are still arriving.","value":10823,"unit":"device adverse event reports received","reports":10823,"deaths":1,"injuries":12,"malfunctions":10809,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NAY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2026 Q3: 9,372 adverse event reports received by the FDA (34 death, 612 injury, 8,637 malfunction and 89 other). Recent quarter: reports are still arriving.","value":9372,"unit":"device adverse event reports received","reports":9372,"deaths":34,"injuries":612,"malfunctions":8637,"other":89,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FDF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2026 Q3: 9,366 adverse event reports received by the FDA (0 death, 29 injury, 9,336 malfunction and 1 other). Recent quarter: reports are still arriving.","value":9366,"unit":"device adverse event reports received","reports":9366,"deaths":0,"injuries":29,"malfunctions":9336,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LGW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2026 Q3: 8,221 adverse event reports received by the FDA (103 death, 6,860 injury, 1,190 malfunction and 68 other). Recent quarter: reports are still arriving.","value":8221,"unit":"device adverse event reports received","reports":8221,"deaths":103,"injuries":6860,"malfunctions":1190,"other":68,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FTR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2026 Q3: 8,122 adverse event reports received by the FDA (2 death, 7,968 injury, 126 malfunction and 26 other). Recent quarter: reports are still arriving.","value":8122,"unit":"device adverse event reports received","reports":8122,"deaths":2,"injuries":7968,"malfunctions":126,"other":26,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DTB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2026 Q3: 6,237 adverse event reports received by the FDA (29 death, 2,284 injury, 3,896 malfunction and 28 other). Recent quarter: reports are still arriving.","value":6237,"unit":"device adverse event reports received","reports":6237,"deaths":29,"injuries":2284,"malfunctions":3896,"other":28,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LWS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2026 Q3: 5,695 adverse event reports received by the FDA (32 death, 2,863 injury, 2,778 malfunction and 22 other). Recent quarter: reports are still arriving.","value":5695,"unit":"device adverse event reports received","reports":5695,"deaths":32,"injuries":2863,"malfunctions":2778,"other":22,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NVN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2026 Q3: 5,607 adverse event reports received by the FDA (43 death, 3,147 injury, 2,347 malfunction and 70 other). Recent quarter: reports are still arriving.","value":5607,"unit":"device adverse event reports received","reports":5607,"deaths":43,"injuries":3147,"malfunctions":2347,"other":70,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:IOR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2026 Q3: 5,459 adverse event reports received by the FDA (0 death, 15 injury, 5,417 malfunction and 27 other). Recent quarter: reports are still arriving.","value":5459,"unit":"device adverse event reports received","reports":5459,"deaths":0,"injuries":15,"malfunctions":5417,"other":27,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NAD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2026 Q3: 5,454 adverse event reports received by the FDA (0 death, 15 injury, 5,436 malfunction and 3 other). Recent quarter: reports are still arriving.","value":5454,"unit":"device adverse event reports received","reports":5454,"deaths":0,"injuries":15,"malfunctions":5436,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LWP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2026 Q3: 4,719 adverse event reports received by the FDA (19 death, 1,115 injury, 3,584 malfunction and 1 other). Recent quarter: reports are still arriving.","value":4719,"unit":"device adverse event reports received","reports":4719,"deaths":19,"injuries":1115,"malfunctions":3584,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FET:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2026 Q3: 4,520 adverse event reports received by the FDA (0 death, 8 injury, 4,512 malfunction and 0 other). Recent quarter: reports are still arriving.","value":4520,"unit":"device adverse event reports received","reports":4520,"deaths":0,"injuries":8,"malfunctions":4512,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DXN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2026 Q3: 4,460 adverse event reports received by the FDA (1 death, 9 injury, 4,429 malfunction and 21 other). Recent quarter: reports are still arriving.","value":4460,"unit":"device adverse event reports received","reports":4460,"deaths":1,"injuries":9,"malfunctions":4429,"other":21,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:CBK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2026 Q3: 4,091 adverse event reports received by the FDA (18 death, 59 injury, 4,001 malfunction and 13 other). Recent quarter: reports are still arriving.","value":4091,"unit":"device adverse event reports received","reports":4091,"deaths":18,"injuries":59,"malfunctions":4001,"other":13,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PQF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2026 Q3: 4,036 adverse event reports received by the FDA (0 death, 7 injury, 4,029 malfunction and 0 other). Recent quarter: reports are still arriving.","value":4036,"unit":"device adverse event reports received","reports":4036,"deaths":0,"injuries":7,"malfunctions":4029,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HBE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2026 Q3: 3,591 adverse event reports received by the FDA (0 death, 15 injury, 3,571 malfunction and 5 other). Recent quarter: reports are still arriving.","value":3591,"unit":"device adverse event reports received","reports":3591,"deaths":0,"injuries":15,"malfunctions":3571,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MVK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2026 Q3: 3,270 adverse event reports received by the FDA (65 death, 873 injury, 2,331 malfunction and 1 other). Recent quarter: reports are still arriving.","value":3270,"unit":"device adverse event reports received","reports":3270,"deaths":65,"injuries":873,"malfunctions":2331,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LLI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LLI","deviceName":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (product code LLI), 2026 Q3: 3,225 adverse event reports received by the FDA (0 death, 4 injury, 3,215 malfunction and 6 other). Recent quarter: reports are still arriving.","value":3225,"unit":"device adverse event reports received","reports":3225,"deaths":0,"injuries":4,"malfunctions":3215,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:EOQ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2026 Q3: 3,056 adverse event reports received by the FDA (7 death, 168 injury, 2,877 malfunction and 4 other). Recent quarter: reports are still arriving.","value":3056,"unit":"device adverse event reports received","reports":3056,"deaths":7,"injuries":168,"malfunctions":2877,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OZD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2026 Q3: 3,028 adverse event reports received by the FDA (353 death, 1,299 injury, 1,374 malfunction and 2 other). Recent quarter: reports are still arriving.","value":3028,"unit":"device adverse event reports received","reports":3028,"deaths":353,"injuries":1299,"malfunctions":1374,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FDT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2026 Q3: 3,015 adverse event reports received by the FDA (5 death, 25 injury, 2,984 malfunction and 1 other). Recent quarter: reports are still arriving.","value":3015,"unit":"device adverse event reports received","reports":3015,"deaths":5,"injuries":25,"malfunctions":2984,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LZG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2026 Q3: 3,002 adverse event reports received by the FDA (2 death, 216 injury, 2,765 malfunction and 19 other). Recent quarter: reports are still arriving.","value":3002,"unit":"device adverse event reports received","reports":3002,"deaths":2,"injuries":216,"malfunctions":2765,"other":19,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:INM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"INM","deviceName":"Chair, With Casters","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Chair, With Casters (product code INM), 2026 Q3: 2,968 adverse event reports received by the FDA (0 death, 6 injury, 2,954 malfunction and 8 other). Recent quarter: reports are still arriving.","value":2968,"unit":"device adverse event reports received","reports":2968,"deaths":0,"injuries":6,"malfunctions":2954,"other":8,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MKJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2026 Q3: 2,966 adverse event reports received by the FDA (34 death, 46 injury, 2,879 malfunction and 7 other). Recent quarter: reports are still arriving.","value":2966,"unit":"device adverse event reports received","reports":2966,"deaths":34,"injuries":46,"malfunctions":2879,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NPT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2026 Q3: 2,940 adverse event reports received by the FDA (202 death, 2,058 injury, 679 malfunction and 1 other). Recent quarter: reports are still arriving.","value":2940,"unit":"device adverse event reports received","reports":2940,"deaths":202,"injuries":2058,"malfunctions":679,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:BTI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Compressor, Air, Portable (product code BTI), 2026 Q3: 2,840 adverse event reports received by the FDA (1 death, 7 injury, 2,816 malfunction and 16 other). Recent quarter: reports are still arriving.","value":2840,"unit":"device adverse event reports received","reports":2840,"deaths":1,"injuries":7,"malfunctions":2816,"other":16,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QJI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJI","deviceName":"Interoperable Automated Glycemic Controller","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Interoperable Automated Glycemic Controller (product code QJI), 2026 Q3: 2,787 adverse event reports received by the FDA (2 death, 938 injury, 1,846 malfunction and 1 other). Recent quarter: reports are still arriving.","value":2787,"unit":"device adverse event reports received","reports":2787,"deaths":2,"injuries":938,"malfunctions":1846,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NVY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2026 Q3: 2,775 adverse event reports received by the FDA (19 death, 1,474 injury, 1,252 malfunction and 30 other). Recent quarter: reports are still arriving.","value":2775,"unit":"device adverse event reports received","reports":2775,"deaths":19,"injuries":1474,"malfunctions":1252,"other":30,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NIK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2026 Q3: 2,694 adverse event reports received by the FDA (32 death, 1,009 injury, 1,643 malfunction and 10 other). Recent quarter: reports are still arriving.","value":2694,"unit":"device adverse event reports received","reports":2694,"deaths":32,"injuries":1009,"malfunctions":1643,"other":10,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GDW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Staple, Implantable (product code GDW), 2026 Q3: 2,659 adverse event reports received by the FDA (7 death, 331 injury, 2,303 malfunction and 18 other). Recent quarter: reports are still arriving.","value":2659,"unit":"device adverse event reports received","reports":2659,"deaths":7,"injuries":331,"malfunctions":2303,"other":18,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LRO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"General Surgery Tray (product code LRO), 2026 Q3: 2,599 adverse event reports received by the FDA (0 death, 64 injury, 2,528 malfunction and 7 other). Recent quarter: reports are still arriving.","value":2599,"unit":"device adverse event reports received","reports":2599,"deaths":0,"injuries":64,"malfunctions":2528,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ILS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Adaptor, Hygiene (product code ILS), 2026 Q3: 2,561 adverse event reports received by the FDA (0 death, 9 injury, 2,537 malfunction and 15 other). Recent quarter: reports are still arriving.","value":2561,"unit":"device adverse event reports received","reports":2561,"deaths":0,"injuries":9,"malfunctions":2537,"other":15,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OYC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2026 Q3: 2,282 adverse event reports received by the FDA (0 death, 6 injury, 2,276 malfunction and 0 other). Recent quarter: reports are still arriving.","value":2282,"unit":"device adverse event reports received","reports":2282,"deaths":0,"injuries":6,"malfunctions":2276,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FWM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2026 Q3: 2,242 adverse event reports received by the FDA (0 death, 2,225 injury, 16 malfunction and 1 other). Recent quarter: reports are still arriving.","value":2242,"unit":"device adverse event reports received","reports":2242,"deaths":0,"injuries":2225,"malfunctions":16,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DSQ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2026 Q3: 2,225 adverse event reports received by the FDA (353 death, 751 injury, 1,111 malfunction and 10 other). Recent quarter: reports are still arriving.","value":2225,"unit":"device adverse event reports received","reports":2225,"deaths":353,"injuries":751,"malfunctions":1111,"other":10,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ODG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2026 Q3: 2,195 adverse event reports received by the FDA (1 death, 7 injury, 2,185 malfunction and 2 other). Recent quarter: reports are still arriving.","value":2195,"unit":"device adverse event reports received","reports":2195,"deaths":1,"injuries":7,"malfunctions":2185,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DSP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2026 Q3: 2,128 adverse event reports received by the FDA (14 death, 40 injury, 2,059 malfunction and 15 other). Recent quarter: reports are still arriving.","value":2128,"unit":"device adverse event reports received","reports":2128,"deaths":14,"injuries":40,"malfunctions":2059,"other":15,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GCJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2026 Q3: 2,052 adverse event reports received by the FDA (1 death, 70 injury, 1,970 malfunction and 11 other). Recent quarter: reports are still arriving.","value":2052,"unit":"device adverse event reports received","reports":2052,"deaths":1,"injuries":70,"malfunctions":1970,"other":11,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GAM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2026 Q3: 2,049 adverse event reports received by the FDA (0 death, 278 injury, 1,762 malfunction and 9 other). Recent quarter: reports are still arriving.","value":2049,"unit":"device adverse event reports received","reports":2049,"deaths":0,"injuries":278,"malfunctions":1762,"other":9,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:SFI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SFI","deviceName":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System (product code SFI), 2026 Q3: 1,983 adverse event reports received by the FDA (0 death, 46 injury, 1,937 malfunction and 0 other). Recent quarter: reports are still arriving.","value":1983,"unit":"device adverse event reports received","reports":1983,"deaths":0,"injuries":46,"malfunctions":1937,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GEI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2026 Q3: 1,969 adverse event reports received by the FDA (3 death, 205 injury, 1,734 malfunction and 27 other). Recent quarter: reports are still arriving.","value":1969,"unit":"device adverse event reports received","reports":1969,"deaths":3,"injuries":205,"malfunctions":1734,"other":27,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:BSZ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2026 Q3: 1,939 adverse event reports received by the FDA (1 death, 15 injury, 1,917 malfunction and 6 other). Recent quarter: reports are still arriving.","value":1939,"unit":"device adverse event reports received","reports":1939,"deaths":1,"injuries":15,"malfunctions":1917,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JWH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2026 Q3: 1,910 adverse event reports received by the FDA (2 death, 1,735 injury, 167 malfunction and 6 other). Recent quarter: reports are still arriving.","value":1910,"unit":"device adverse event reports received","reports":1910,"deaths":2,"injuries":1735,"malfunctions":167,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:EZW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2026 Q3: 1,875 adverse event reports received by the FDA (0 death, 1,421 injury, 440 malfunction and 14 other). Recent quarter: reports are still arriving.","value":1875,"unit":"device adverse event reports received","reports":1875,"deaths":0,"injuries":1421,"malfunctions":440,"other":14,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FAJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2026 Q3: 1,864 adverse event reports received by the FDA (1 death, 10 injury, 1,853 malfunction and 0 other). Recent quarter: reports are still arriving.","value":1864,"unit":"device adverse event reports received","reports":1864,"deaths":1,"injuries":10,"malfunctions":1853,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FSA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2026 Q3: 1,809 adverse event reports received by the FDA (12 death, 25 injury, 1,761 malfunction and 11 other). Recent quarter: reports are still arriving.","value":1809,"unit":"device adverse event reports received","reports":1809,"deaths":12,"injuries":25,"malfunctions":1761,"other":11,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DYB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Introducer, Catheter (product code DYB), 2026 Q3: 1,597 adverse event reports received by the FDA (45 death, 437 injury, 1,091 malfunction and 24 other). Recent quarter: reports are still arriving.","value":1597,"unit":"device adverse event reports received","reports":1597,"deaths":45,"injuries":437,"malfunctions":1091,"other":24,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FMF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Syringe, Piston (product code FMF), 2026 Q3: 1,597 adverse event reports received by the FDA (0 death, 134 injury, 1,448 malfunction and 15 other). Recent quarter: reports are still arriving.","value":1597,"unit":"device adverse event reports received","reports":1597,"deaths":0,"injuries":134,"malfunctions":1448,"other":15,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JKA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2026 Q3: 1,552 adverse event reports received by the FDA (0 death, 32 injury, 1,518 malfunction and 2 other). Recent quarter: reports are still arriving.","value":1552,"unit":"device adverse event reports received","reports":1552,"deaths":0,"injuries":32,"malfunctions":1518,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QZI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2026 Q3: 1,544 adverse event reports received by the FDA (36 death, 772 injury, 706 malfunction and 30 other). Recent quarter: reports are still arriving.","value":1544,"unit":"device adverse event reports received","reports":1544,"deaths":36,"injuries":772,"malfunctions":706,"other":30,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PNJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Leadless Pacemaker (product code PNJ), 2026 Q3: 1,531 adverse event reports received by the FDA (60 death, 550 injury, 918 malfunction and 3 other). Recent quarter: reports are still arriving.","value":1531,"unit":"device adverse event reports received","reports":1531,"deaths":60,"injuries":550,"malfunctions":918,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LKK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2026 Q3: 1,504 adverse event reports received by the FDA (5 death, 656 injury, 831 malfunction and 12 other). Recent quarter: reports are still arriving.","value":1504,"unit":"device adverse event reports received","reports":1504,"deaths":5,"injuries":656,"malfunctions":831,"other":12,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NBW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2026 Q3: 1,490 adverse event reports received by the FDA (1 death, 54 injury, 1,415 malfunction and 20 other). Recent quarter: reports are still arriving.","value":1490,"unit":"device adverse event reports received","reports":1490,"deaths":1,"injuries":54,"malfunctions":1415,"other":20,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MGB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2026 Q3: 1,485 adverse event reports received by the FDA (4 death, 267 injury, 1,201 malfunction and 13 other). Recent quarter: reports are still arriving.","value":1485,"unit":"device adverse event reports received","reports":1485,"deaths":4,"injuries":267,"malfunctions":1201,"other":13,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JJE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2026 Q3: 1,476 adverse event reports received by the FDA (0 death, 22 injury, 1,449 malfunction and 5 other). Recent quarter: reports are still arriving.","value":1476,"unit":"device adverse event reports received","reports":1476,"deaths":0,"injuries":22,"malfunctions":1449,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NVZ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2026 Q3: 1,448 adverse event reports received by the FDA (22 death, 738 injury, 681 malfunction and 7 other). Recent quarter: reports are still arriving.","value":1448,"unit":"device adverse event reports received","reports":1448,"deaths":22,"injuries":738,"malfunctions":681,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MCM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Implant, Cochlear (product code MCM), 2026 Q3: 1,439 adverse event reports received by the FDA (1 death, 1,011 injury, 426 malfunction and 1 other). Recent quarter: reports are still arriving.","value":1439,"unit":"device adverse event reports received","reports":1439,"deaths":1,"injuries":1011,"malfunctions":426,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LXH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2026 Q3: 1,406 adverse event reports received by the FDA (0 death, 67 injury, 1,330 malfunction and 9 other). Recent quarter: reports are still arriving.","value":1406,"unit":"device adverse event reports received","reports":1406,"deaths":0,"injuries":67,"malfunctions":1330,"other":9,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PSV:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2026 Q3: 1,396 adverse event reports received by the FDA (0 death, 25 injury, 1,371 malfunction and 0 other). Recent quarter: reports are still arriving.","value":1396,"unit":"device adverse event reports received","reports":1396,"deaths":0,"injuries":25,"malfunctions":1371,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MHX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2026 Q3: 1,386 adverse event reports received by the FDA (32 death, 253 injury, 1,086 malfunction and 15 other). Recent quarter: reports are still arriving.","value":1386,"unit":"device adverse event reports received","reports":1386,"deaths":32,"injuries":253,"malfunctions":1086,"other":15,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:BTT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2026 Q3: 1,363 adverse event reports received by the FDA (0 death, 6 injury, 1,353 malfunction and 4 other). Recent quarter: reports are still arriving.","value":1363,"unit":"device adverse event reports received","reports":1363,"deaths":0,"injuries":6,"malfunctions":1353,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LPH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2026 Q3: 1,353 adverse event reports received by the FDA (0 death, 1,107 injury, 245 malfunction and 1 other). Recent quarter: reports are still arriving.","value":1353,"unit":"device adverse event reports received","reports":1353,"deaths":0,"injuries":1107,"malfunctions":245,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MNT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2026 Q3: 1,338 adverse event reports received by the FDA (5 death, 8 injury, 1,325 malfunction and 0 other). Recent quarter: reports are still arriving.","value":1338,"unit":"device adverse event reports received","reports":1338,"deaths":5,"injuries":8,"malfunctions":1325,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LJT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2026 Q3: 1,281 adverse event reports received by the FDA (61 death, 874 injury, 344 malfunction and 2 other). Recent quarter: reports are still arriving.","value":1281,"unit":"device adverse event reports received","reports":1281,"deaths":61,"injuries":874,"malfunctions":344,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HQL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Intraocular Lens (product code HQL), 2026 Q3: 1,262 adverse event reports received by the FDA (0 death, 272 injury, 982 malfunction and 8 other). Recent quarter: reports are still arriving.","value":1262,"unit":"device adverse event reports received","reports":1262,"deaths":0,"injuries":272,"malfunctions":982,"other":8,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KNW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Instrument, Biopsy (product code KNW), 2026 Q3: 1,245 adverse event reports received by the FDA (0 death, 101 injury, 1,133 malfunction and 11 other). Recent quarter: reports are still arriving.","value":1245,"unit":"device adverse event reports received","reports":1245,"deaths":0,"injuries":101,"malfunctions":1133,"other":11,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FNL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2026 Q3: 1,219 adverse event reports received by the FDA (5 death, 17 injury, 1,194 malfunction and 3 other). Recent quarter: reports are still arriving.","value":1219,"unit":"device adverse event reports received","reports":1219,"deaths":5,"injuries":17,"malfunctions":1194,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FMI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2026 Q3: 1,201 adverse event reports received by the FDA (6 death, 81 injury, 1,104 malfunction and 10 other). Recent quarter: reports are still arriving.","value":1201,"unit":"device adverse event reports received","reports":1201,"deaths":6,"injuries":81,"malfunctions":1104,"other":10,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LFL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2026 Q3: 1,175 adverse event reports received by the FDA (0 death, 27 injury, 1,145 malfunction and 3 other). Recent quarter: reports are still arriving.","value":1175,"unit":"device adverse event reports received","reports":1175,"deaths":0,"injuries":27,"malfunctions":1145,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OWB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2026 Q3: 1,141 adverse event reports received by the FDA (4 death, 17 injury, 1,119 malfunction and 1 other). Recent quarter: reports are still arriving.","value":1141,"unit":"device adverse event reports received","reports":1141,"deaths":4,"injuries":17,"malfunctions":1119,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MBI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2026 Q3: 1,132 adverse event reports received by the FDA (0 death, 82 injury, 1,041 malfunction and 9 other). Recent quarter: reports are still arriving.","value":1132,"unit":"device adverse event reports received","reports":1132,"deaths":0,"injuries":82,"malfunctions":1041,"other":9,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HET:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2026 Q3: 1,118 adverse event reports received by the FDA (0 death, 3 injury, 1,114 malfunction and 1 other). Recent quarter: reports are still arriving.","value":1118,"unit":"device adverse event reports received","reports":1118,"deaths":0,"injuries":3,"malfunctions":1114,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:EOB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2026 Q3: 1,113 adverse event reports received by the FDA (0 death, 4 injury, 1,109 malfunction and 0 other). Recent quarter: reports are still arriving.","value":1113,"unit":"device adverse event reports received","reports":1113,"deaths":0,"injuries":4,"malfunctions":1109,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FOZ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2026 Q3: 1,095 adverse event reports received by the FDA (2 death, 85 injury, 993 malfunction and 15 other). Recent quarter: reports are still arriving.","value":1095,"unit":"device adverse event reports received","reports":1095,"deaths":2,"injuries":85,"malfunctions":993,"other":15,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FGB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2026 Q3: 1,023 adverse event reports received by the FDA (0 death, 12 injury, 1,008 malfunction and 3 other). Recent quarter: reports are still arriving.","value":1023,"unit":"device adverse event reports received","reports":1023,"deaths":0,"injuries":12,"malfunctions":1008,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GAT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2026 Q3: 995 adverse event reports received by the FDA (1 death, 69 injury, 920 malfunction and 5 other). Recent quarter: reports are still arriving.","value":995,"unit":"device adverse event reports received","reports":995,"deaths":1,"injuries":69,"malfunctions":920,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HWC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2026 Q3: 955 adverse event reports received by the FDA (0 death, 527 injury, 425 malfunction and 3 other). Recent quarter: reports are still arriving.","value":955,"unit":"device adverse event reports received","reports":955,"deaths":0,"injuries":527,"malfunctions":425,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MNS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2026 Q3: 911 adverse event reports received by the FDA (0 death, 7 injury, 904 malfunction and 0 other). Recent quarter: reports are still arriving.","value":911,"unit":"device adverse event reports received","reports":911,"deaths":0,"injuries":7,"malfunctions":904,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MHY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2026 Q3: 887 adverse event reports received by the FDA (21 death, 505 injury, 357 malfunction and 4 other). Recent quarter: reports are still arriving.","value":887,"unit":"device adverse event reports received","reports":887,"deaths":21,"injuries":505,"malfunctions":357,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OSI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Bariatric Bed (product code OSI), 2026 Q3: 885 adverse event reports received by the FDA (0 death, 3 injury, 878 malfunction and 4 other). Recent quarter: reports are still arriving.","value":885,"unit":"device adverse event reports received","reports":885,"deaths":0,"injuries":3,"malfunctions":878,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:SBA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2026 Q3: 883 adverse event reports received by the FDA (0 death, 139 injury, 732 malfunction and 12 other). Recent quarter: reports are still arriving.","value":883,"unit":"device adverse event reports received","reports":883,"deaths":0,"injuries":139,"malfunctions":732,"other":12,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DQY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Percutaneous (product code DQY), 2026 Q3: 846 adverse event reports received by the FDA (15 death, 223 injury, 605 malfunction and 3 other). Recent quarter: reports are still arriving.","value":846,"unit":"device adverse event reports received","reports":846,"deaths":15,"injuries":223,"malfunctions":605,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FKX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2026 Q3: 823 adverse event reports received by the FDA (16 death, 418 injury, 384 malfunction and 5 other). Recent quarter: reports are still arriving.","value":823,"unit":"device adverse event reports received","reports":823,"deaths":16,"injuries":418,"malfunctions":384,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OJX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2026 Q3: 784 adverse event reports received by the FDA (6 death, 444 injury, 326 malfunction and 8 other). Recent quarter: reports are still arriving.","value":784,"unit":"device adverse event reports received","reports":784,"deaths":6,"injuries":444,"malfunctions":326,"other":8,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NWB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2026 Q3: 783 adverse event reports received by the FDA (0 death, 1 injury, 782 malfunction and 0 other). Recent quarter: reports are still arriving.","value":783,"unit":"device adverse event reports received","reports":783,"deaths":0,"injuries":1,"malfunctions":782,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MIH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2026 Q3: 765 adverse event reports received by the FDA (38 death, 589 injury, 137 malfunction and 1 other). Recent quarter: reports are still arriving.","value":765,"unit":"device adverse event reports received","reports":765,"deaths":38,"injuries":589,"malfunctions":137,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OLO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2026 Q3: 765 adverse event reports received by the FDA (0 death, 85 injury, 674 malfunction and 6 other). Recent quarter: reports are still arriving.","value":765,"unit":"device adverse event reports received","reports":765,"deaths":0,"injuries":85,"malfunctions":674,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GAW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2026 Q3: 764 adverse event reports received by the FDA (0 death, 168 injury, 595 malfunction and 1 other). Recent quarter: reports are still arriving.","value":764,"unit":"device adverse event reports received","reports":764,"deaths":0,"injuries":168,"malfunctions":595,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LZO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2026 Q3: 752 adverse event reports received by the FDA (1 death, 655 injury, 96 malfunction and 0 other). Recent quarter: reports are still arriving.","value":752,"unit":"device adverse event reports received","reports":752,"deaths":1,"injuries":655,"malfunctions":96,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HSB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2026 Q3: 735 adverse event reports received by the FDA (0 death, 452 injury, 282 malfunction and 1 other). Recent quarter: reports are still arriving.","value":735,"unit":"device adverse event reports received","reports":735,"deaths":0,"injuries":452,"malfunctions":282,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MEA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2026 Q3: 734 adverse event reports received by the FDA (1 death, 3 injury, 729 malfunction and 1 other). Recent quarter: reports are still arriving.","value":734,"unit":"device adverse event reports received","reports":734,"deaths":1,"injuries":3,"malfunctions":729,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LJS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2026 Q3: 732 adverse event reports received by the FDA (1 death, 112 injury, 610 malfunction and 9 other). Recent quarter: reports are still arriving.","value":732,"unit":"device adverse event reports received","reports":732,"deaths":1,"injuries":112,"malfunctions":610,"other":9,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NHA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2026 Q3: 727 adverse event reports received by the FDA (0 death, 550 injury, 175 malfunction and 2 other). Recent quarter: reports are still arriving.","value":727,"unit":"device adverse event reports received","reports":727,"deaths":0,"injuries":550,"malfunctions":175,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NKE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2026 Q3: 719 adverse event reports received by the FDA (3 death, 194 injury, 520 malfunction and 2 other). Recent quarter: reports are still arriving.","value":719,"unit":"device adverse event reports received","reports":719,"deaths":3,"injuries":194,"malfunctions":520,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MXD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2026 Q3: 716 adverse event reports received by the FDA (0 death, 106 injury, 609 malfunction and 1 other). Recent quarter: reports are still arriving.","value":716,"unit":"device adverse event reports received","reports":716,"deaths":0,"injuries":106,"malfunctions":609,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DTZ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2026 Q3: 711 adverse event reports received by the FDA (2 death, 19 injury, 689 malfunction and 1 other). Recent quarter: reports are still arriving.","value":711,"unit":"device adverse event reports received","reports":711,"deaths":2,"injuries":19,"malfunctions":689,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FNM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2026 Q3: 707 adverse event reports received by the FDA (0 death, 14 injury, 681 malfunction and 12 other). Recent quarter: reports are still arriving.","value":707,"unit":"device adverse event reports received","reports":707,"deaths":0,"injuries":14,"malfunctions":681,"other":12,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NKM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2026 Q3: 707 adverse event reports received by the FDA (37 death, 442 injury, 228 malfunction and 0 other). Recent quarter: reports are still arriving.","value":707,"unit":"device adverse event reports received","reports":707,"deaths":37,"injuries":442,"malfunctions":228,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NIQ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2026 Q3: 703 adverse event reports received by the FDA (38 death, 292 injury, 367 malfunction and 6 other). Recent quarter: reports are still arriving.","value":703,"unit":"device adverse event reports received","reports":703,"deaths":38,"injuries":292,"malfunctions":367,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NDP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2026 Q3: 693 adverse event reports received by the FDA (0 death, 38 injury, 654 malfunction and 1 other). Recent quarter: reports are still arriving.","value":693,"unit":"device adverse event reports received","reports":693,"deaths":0,"injuries":38,"malfunctions":654,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:SCV:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SCV","deviceName":"Modular Electromechanical Surgical System","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Modular Electromechanical Surgical System (product code SCV), 2026 Q3: 690 adverse event reports received by the FDA (0 death, 21 injury, 668 malfunction and 1 other). Recent quarter: reports are still arriving.","value":690,"unit":"device adverse event reports received","reports":690,"deaths":0,"injuries":21,"malfunctions":668,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LMH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2026 Q3: 682 adverse event reports received by the FDA (0 death, 678 injury, 0 malfunction and 4 other). Recent quarter: reports are still arriving.","value":682,"unit":"device adverse event reports received","reports":682,"deaths":0,"injuries":678,"malfunctions":0,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OJH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Orthopedic Tray (product code OJH), 2026 Q3: 679 adverse event reports received by the FDA (0 death, 13 injury, 663 malfunction and 3 other). Recent quarter: reports are still arriving.","value":679,"unit":"device adverse event reports received","reports":679,"deaths":0,"injuries":13,"malfunctions":663,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GEX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2026 Q3: 678 adverse event reports received by the FDA (2 death, 78 injury, 591 malfunction and 7 other). Recent quarter: reports are still arriving.","value":678,"unit":"device adverse event reports received","reports":678,"deaths":2,"injuries":78,"malfunctions":591,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PHX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2026 Q3: 676 adverse event reports received by the FDA (0 death, 589 injury, 85 malfunction and 2 other). Recent quarter: reports are still arriving.","value":676,"unit":"device adverse event reports received","reports":676,"deaths":0,"injuries":589,"malfunctions":85,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KWS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2026 Q3: 671 adverse event reports received by the FDA (0 death, 636 injury, 35 malfunction and 0 other). Recent quarter: reports are still arriving.","value":671,"unit":"device adverse event reports received","reports":671,"deaths":0,"injuries":636,"malfunctions":35,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MAI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2026 Q3: 668 adverse event reports received by the FDA (0 death, 51 injury, 617 malfunction and 0 other). Recent quarter: reports are still arriving.","value":668,"unit":"device adverse event reports received","reports":668,"deaths":0,"injuries":51,"malfunctions":617,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KDI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2026 Q3: 645 adverse event reports received by the FDA (28 death, 68 injury, 546 malfunction and 3 other). Recent quarter: reports are still arriving.","value":645,"unit":"device adverse event reports received","reports":645,"deaths":28,"injuries":68,"malfunctions":546,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FHW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2026 Q3: 637 adverse event reports received by the FDA (0 death, 595 injury, 40 malfunction and 2 other). Recent quarter: reports are still arriving.","value":637,"unit":"device adverse event reports received","reports":637,"deaths":0,"injuries":595,"malfunctions":40,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FTL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2026 Q3: 613 adverse event reports received by the FDA (23 death, 546 injury, 38 malfunction and 6 other). Recent quarter: reports are still arriving.","value":613,"unit":"device adverse event reports received","reports":613,"deaths":23,"injuries":546,"malfunctions":38,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HQC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2026 Q3: 596 adverse event reports received by the FDA (0 death, 172 injury, 422 malfunction and 2 other). Recent quarter: reports are still arriving.","value":596,"unit":"device adverse event reports received","reports":596,"deaths":0,"injuries":172,"malfunctions":422,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FGE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2026 Q3: 591 adverse event reports received by the FDA (3 death, 95 injury, 486 malfunction and 7 other). Recent quarter: reports are still arriving.","value":591,"unit":"device adverse event reports received","reports":591,"deaths":3,"injuries":95,"malfunctions":486,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HRX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Arthroscope (product code HRX), 2026 Q3: 581 adverse event reports received by the FDA (0 death, 20 injury, 559 malfunction and 2 other). Recent quarter: reports are still arriving.","value":581,"unit":"device adverse event reports received","reports":581,"deaths":0,"injuries":20,"malfunctions":559,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HWE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2026 Q3: 579 adverse event reports received by the FDA (0 death, 11 injury, 564 malfunction and 4 other). Recent quarter: reports are still arriving.","value":579,"unit":"device adverse event reports received","reports":579,"deaths":0,"injuries":11,"malfunctions":564,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LIT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2026 Q3: 575 adverse event reports received by the FDA (0 death, 56 injury, 517 malfunction and 2 other). Recent quarter: reports are still arriving.","value":575,"unit":"device adverse event reports received","reports":575,"deaths":0,"injuries":56,"malfunctions":517,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HBB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2026 Q3: 573 adverse event reports received by the FDA (0 death, 3 injury, 570 malfunction and 0 other). Recent quarter: reports are still arriving.","value":573,"unit":"device adverse event reports received","reports":573,"deaths":0,"injuries":3,"malfunctions":570,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DRA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Steerable (product code DRA), 2026 Q3: 567 adverse event reports received by the FDA (7 death, 167 injury, 390 malfunction and 3 other). Recent quarter: reports are still arriving.","value":567,"unit":"device adverse event reports received","reports":567,"deaths":7,"injuries":167,"malfunctions":390,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LWR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2026 Q3: 567 adverse event reports received by the FDA (16 death, 482 injury, 67 malfunction and 2 other). Recent quarter: reports are still arriving.","value":567,"unit":"device adverse event reports received","reports":567,"deaths":16,"injuries":482,"malfunctions":67,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:EZY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2026 Q3: 566 adverse event reports received by the FDA (0 death, 562 injury, 4 malfunction and 0 other). Recent quarter: reports are still arriving.","value":566,"unit":"device adverse event reports received","reports":566,"deaths":0,"injuries":562,"malfunctions":4,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GAG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stapler, Surgical (product code GAG), 2026 Q3: 555 adverse event reports received by the FDA (3 death, 57 injury, 494 malfunction and 1 other). Recent quarter: reports are still arriving.","value":555,"unit":"device adverse event reports received","reports":555,"deaths":3,"injuries":57,"malfunctions":494,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NEW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2026 Q3: 553 adverse event reports received by the FDA (0 death, 114 injury, 439 malfunction and 0 other). Recent quarter: reports are still arriving.","value":553,"unit":"device adverse event reports received","reports":553,"deaths":0,"injuries":114,"malfunctions":439,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KNT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2026 Q3: 545 adverse event reports received by the FDA (6 death, 190 injury, 337 malfunction and 12 other). Recent quarter: reports are still arriving.","value":545,"unit":"device adverse event reports received","reports":545,"deaths":6,"injuries":190,"malfunctions":337,"other":12,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NGV:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2026 Q3: 545 adverse event reports received by the FDA (42 death, 464 injury, 34 malfunction and 5 other). Recent quarter: reports are still arriving.","value":545,"unit":"device adverse event reports received","reports":545,"deaths":42,"injuries":464,"malfunctions":34,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PMP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2026 Q3: 536 adverse event reports received by the FDA (0 death, 527 injury, 5 malfunction and 4 other). Recent quarter: reports are still arriving.","value":536,"unit":"device adverse event reports received","reports":536,"deaths":0,"injuries":527,"malfunctions":5,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FZP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Clip, Implantable (product code FZP), 2026 Q3: 535 adverse event reports received by the FDA (1 death, 19 injury, 511 malfunction and 4 other). Recent quarter: reports are still arriving.","value":535,"unit":"device adverse event reports received","reports":535,"deaths":1,"injuries":19,"malfunctions":511,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HWA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Impactor (product code HWA), 2026 Q3: 521 adverse event reports received by the FDA (0 death, 1 injury, 520 malfunction and 0 other). Recent quarter: reports are still arriving.","value":521,"unit":"device adverse event reports received","reports":521,"deaths":0,"injuries":1,"malfunctions":520,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HXX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Screwdriver (product code HXX), 2026 Q3: 516 adverse event reports received by the FDA (0 death, 6 injury, 510 malfunction and 0 other). Recent quarter: reports are still arriving.","value":516,"unit":"device adverse event reports received","reports":516,"deaths":0,"injuries":6,"malfunctions":510,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KGX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2026 Q3: 515 adverse event reports received by the FDA (2 death, 77 injury, 379 malfunction and 57 other). Recent quarter: reports are still arriving.","value":515,"unit":"device adverse event reports received","reports":515,"deaths":2,"injuries":77,"malfunctions":379,"other":57,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MDS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2026 Q3: 512 adverse event reports received by the FDA (0 death, 16 injury, 496 malfunction and 0 other). Recent quarter: reports are still arriving.","value":512,"unit":"device adverse event reports received","reports":512,"deaths":0,"injuries":16,"malfunctions":496,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HRS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2026 Q3: 510 adverse event reports received by the FDA (0 death, 378 injury, 132 malfunction and 0 other). Recent quarter: reports are still arriving.","value":510,"unit":"device adverse event reports received","reports":510,"deaths":0,"injuries":378,"malfunctions":132,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KDJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2026 Q3: 510 adverse event reports received by the FDA (4 death, 277 injury, 229 malfunction and 0 other). Recent quarter: reports are still arriving.","value":510,"unit":"device adverse event reports received","reports":510,"deaths":4,"injuries":277,"malfunctions":229,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MOM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2026 Q3: 502 adverse event reports received by the FDA (0 death, 168 injury, 331 malfunction and 3 other). Recent quarter: reports are still arriving.","value":502,"unit":"device adverse event reports received","reports":502,"deaths":0,"injuries":168,"malfunctions":331,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HIH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2026 Q3: 498 adverse event reports received by the FDA (0 death, 45 injury, 451 malfunction and 2 other). Recent quarter: reports are still arriving.","value":498,"unit":"device adverse event reports received","reports":498,"deaths":0,"injuries":45,"malfunctions":451,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QCB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2026 Q3: 495 adverse event reports received by the FDA (0 death, 495 injury, 0 malfunction and 0 other). Recent quarter: reports are still arriving.","value":495,"unit":"device adverse event reports received","reports":495,"deaths":0,"injuries":495,"malfunctions":0,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DQX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2026 Q3: 492 adverse event reports received by the FDA (15 death, 197 injury, 258 malfunction and 22 other). Recent quarter: reports are still arriving.","value":492,"unit":"device adverse event reports received","reports":492,"deaths":15,"injuries":197,"malfunctions":258,"other":22,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MJP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2026 Q3: 488 adverse event reports received by the FDA (0 death, 209 injury, 279 malfunction and 0 other). Recent quarter: reports are still arriving.","value":488,"unit":"device adverse event reports received","reports":488,"deaths":0,"injuries":209,"malfunctions":279,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FJK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2026 Q3: 487 adverse event reports received by the FDA (0 death, 5 injury, 480 malfunction and 2 other). Recent quarter: reports are still arriving.","value":487,"unit":"device adverse event reports received","reports":487,"deaths":0,"injuries":5,"malfunctions":480,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HWT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Template (product code HWT), 2026 Q3: 483 adverse event reports received by the FDA (0 death, 6 injury, 477 malfunction and 0 other). Recent quarter: reports are still arriving.","value":483,"unit":"device adverse event reports received","reports":483,"deaths":0,"injuries":6,"malfunctions":477,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ERL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2026 Q3: 481 adverse event reports received by the FDA (0 death, 0 injury, 481 malfunction and 0 other). Recent quarter: reports are still arriving.","value":481,"unit":"device adverse event reports received","reports":481,"deaths":0,"injuries":0,"malfunctions":481,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OUT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2026 Q3: 474 adverse event reports received by the FDA (19 death, 89 injury, 365 malfunction and 1 other). Recent quarter: reports are still arriving.","value":474,"unit":"device adverse event reports received","reports":474,"deaths":19,"injuries":89,"malfunctions":365,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JDI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2026 Q3: 457 adverse event reports received by the FDA (2 death, 406 injury, 49 malfunction and 0 other). Recent quarter: reports are still arriving.","value":457,"unit":"device adverse event reports received","reports":457,"deaths":2,"injuries":406,"malfunctions":49,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JCW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2026 Q3: 454 adverse event reports received by the FDA (0 death, 440 injury, 14 malfunction and 0 other). Recent quarter: reports are still arriving.","value":454,"unit":"device adverse event reports received","reports":454,"deaths":0,"injuries":440,"malfunctions":14,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:CAF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2026 Q3: 449 adverse event reports received by the FDA (0 death, 11 injury, 408 malfunction and 30 other). Recent quarter: reports are still arriving.","value":449,"unit":"device adverse event reports received","reports":449,"deaths":0,"injuries":11,"malfunctions":408,"other":30,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LRK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Device, Anti-Snoring (product code LRK), 2026 Q3: 443 adverse event reports received by the FDA (0 death, 31 injury, 408 malfunction and 4 other). Recent quarter: reports are still arriving.","value":443,"unit":"device adverse event reports received","reports":443,"deaths":0,"injuries":31,"malfunctions":408,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NZU:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2026 Q3: 434 adverse event reports received by the FDA (0 death, 107 injury, 325 malfunction and 2 other). Recent quarter: reports are still arriving.","value":434,"unit":"device adverse event reports received","reports":434,"deaths":0,"injuries":107,"malfunctions":325,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DYE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Replacement Heart-Valve (product code DYE), 2026 Q3: 430 adverse event reports received by the FDA (9 death, 352 injury, 69 malfunction and 0 other). Recent quarter: reports are still arriving.","value":430,"unit":"device adverse event reports received","reports":430,"deaths":9,"injuries":352,"malfunctions":69,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HTW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Bit, Drill (product code HTW), 2026 Q3: 430 adverse event reports received by the FDA (0 death, 15 injury, 415 malfunction and 0 other). Recent quarter: reports are still arriving.","value":430,"unit":"device adverse event reports received","reports":430,"deaths":0,"injuries":15,"malfunctions":415,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DWJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Thermal Regulating (product code DWJ), 2026 Q3: 417 adverse event reports received by the FDA (2 death, 24 injury, 390 malfunction and 1 other). Recent quarter: reports are still arriving.","value":417,"unit":"device adverse event reports received","reports":417,"deaths":2,"injuries":24,"malfunctions":390,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MBH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2026 Q3: 414 adverse event reports received by the FDA (0 death, 289 injury, 125 malfunction and 0 other). Recent quarter: reports are still arriving.","value":414,"unit":"device adverse event reports received","reports":414,"deaths":0,"injuries":289,"malfunctions":125,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KRD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2026 Q3: 402 adverse event reports received by the FDA (4 death, 80 injury, 316 malfunction and 2 other). Recent quarter: reports are still arriving.","value":402,"unit":"device adverse event reports received","reports":402,"deaths":4,"injuries":80,"malfunctions":316,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DTQ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2026 Q3: 399 adverse event reports received by the FDA (4 death, 3 injury, 392 malfunction and 0 other). Recent quarter: reports are still arriving.","value":399,"unit":"device adverse event reports received","reports":399,"deaths":4,"injuries":3,"malfunctions":392,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MJC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2026 Q3: 395 adverse event reports received by the FDA (0 death, 20 injury, 375 malfunction and 0 other). Recent quarter: reports are still arriving.","value":395,"unit":"device adverse event reports received","reports":395,"deaths":0,"injuries":20,"malfunctions":375,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DQA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Oximeter (product code DQA), 2026 Q3: 391 adverse event reports received by the FDA (3 death, 13 injury, 367 malfunction and 8 other). Recent quarter: reports are still arriving.","value":391,"unit":"device adverse event reports received","reports":391,"deaths":3,"injuries":13,"malfunctions":367,"other":8,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KTT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2026 Q3: 387 adverse event reports received by the FDA (1 death, 29 injury, 357 malfunction and 0 other). Recent quarter: reports are still arriving.","value":387,"unit":"device adverse event reports received","reports":387,"deaths":1,"injuries":29,"malfunctions":357,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KOD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Urological (product code KOD), 2026 Q3: 386 adverse event reports received by the FDA (0 death, 139 injury, 246 malfunction and 1 other). Recent quarter: reports are still arriving.","value":386,"unit":"device adverse event reports received","reports":386,"deaths":0,"injuries":139,"malfunctions":246,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DRM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2026 Q3: 376 adverse event reports received by the FDA (8 death, 10 injury, 356 malfunction and 2 other). Recent quarter: reports are still arriving.","value":376,"unit":"device adverse event reports received","reports":376,"deaths":8,"injuries":10,"malfunctions":356,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HAW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2026 Q3: 369 adverse event reports received by the FDA (1 death, 30 injury, 337 malfunction and 1 other). Recent quarter: reports are still arriving.","value":369,"unit":"device adverse event reports received","reports":369,"deaths":1,"injuries":30,"malfunctions":337,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LYJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2026 Q3: 365 adverse event reports received by the FDA (17 death, 161 injury, 186 malfunction and 1 other). Recent quarter: reports are still arriving.","value":365,"unit":"device adverse event reports received","reports":365,"deaths":17,"injuries":161,"malfunctions":186,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HIF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2026 Q3: 364 adverse event reports received by the FDA (0 death, 18 injury, 344 malfunction and 2 other). Recent quarter: reports are still arriving.","value":364,"unit":"device adverse event reports received","reports":364,"deaths":0,"injuries":18,"malfunctions":344,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KNS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2026 Q3: 355 adverse event reports received by the FDA (1 death, 72 injury, 278 malfunction and 4 other). Recent quarter: reports are still arriving.","value":355,"unit":"device adverse event reports received","reports":355,"deaths":1,"injuries":72,"malfunctions":278,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GAR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2026 Q3: 354 adverse event reports received by the FDA (0 death, 23 injury, 331 malfunction and 0 other). Recent quarter: reports are still arriving.","value":354,"unit":"device adverse event reports received","reports":354,"deaths":0,"injuries":23,"malfunctions":331,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:CCK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2026 Q3: 351 adverse event reports received by the FDA (0 death, 1 injury, 349 malfunction and 1 other). Recent quarter: reports are still arriving.","value":351,"unit":"device adverse event reports received","reports":351,"deaths":0,"injuries":1,"malfunctions":349,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:SAF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2026 Q3: 348 adverse event reports received by the FDA (0 death, 22 injury, 318 malfunction and 8 other). Recent quarter: reports are still arriving.","value":348,"unit":"device adverse event reports received","reports":348,"deaths":0,"injuries":22,"malfunctions":318,"other":8,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MXC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2026 Q3: 344 adverse event reports received by the FDA (0 death, 48 injury, 295 malfunction and 1 other). Recent quarter: reports are still arriving.","value":344,"unit":"device adverse event reports received","reports":344,"deaths":0,"injuries":48,"malfunctions":295,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LOX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2026 Q3: 342 adverse event reports received by the FDA (7 death, 39 injury, 294 malfunction and 2 other). Recent quarter: reports are still arriving.","value":342,"unit":"device adverse event reports received","reports":342,"deaths":7,"injuries":39,"malfunctions":294,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MMI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2026 Q3: 342 adverse event reports received by the FDA (0 death, 6 injury, 336 malfunction and 0 other). Recent quarter: reports are still arriving.","value":342,"unit":"device adverse event reports received","reports":342,"deaths":0,"injuries":6,"malfunctions":336,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:CCW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2026 Q3: 319 adverse event reports received by the FDA (2 death, 16 injury, 301 malfunction and 0 other). Recent quarter: reports are still arriving.","value":319,"unit":"device adverse event reports received","reports":319,"deaths":2,"injuries":16,"malfunctions":301,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:EZL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2026 Q3: 319 adverse event reports received by the FDA (0 death, 21 injury, 296 malfunction and 2 other). Recent quarter: reports are still arriving.","value":319,"unit":"device adverse event reports received","reports":319,"deaths":0,"injuries":21,"malfunctions":296,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HSN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2026 Q3: 318 adverse event reports received by the FDA (0 death, 310 injury, 8 malfunction and 0 other). Recent quarter: reports are still arriving.","value":318,"unit":"device adverse event reports received","reports":318,"deaths":0,"injuries":310,"malfunctions":8,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NOU:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2026 Q3: 316 adverse event reports received by the FDA (10 death, 11 injury, 292 malfunction and 3 other). Recent quarter: reports are still arriving.","value":316,"unit":"device adverse event reports received","reports":316,"deaths":10,"injuries":11,"malfunctions":292,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OBJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2026 Q3: 314 adverse event reports received by the FDA (7 death, 27 injury, 277 malfunction and 3 other). Recent quarter: reports are still arriving.","value":314,"unit":"device adverse event reports received","reports":314,"deaths":7,"injuries":27,"malfunctions":277,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:BTR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2026 Q3: 312 adverse event reports received by the FDA (2 death, 43 injury, 262 malfunction and 5 other). Recent quarter: reports are still arriving.","value":312,"unit":"device adverse event reports received","reports":312,"deaths":2,"injuries":43,"malfunctions":262,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HWR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Driver, Prosthesis (product code HWR), 2026 Q3: 312 adverse event reports received by the FDA (0 death, 11 injury, 301 malfunction and 0 other). Recent quarter: reports are still arriving.","value":312,"unit":"device adverse event reports received","reports":312,"deaths":0,"injuries":11,"malfunctions":301,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NDC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Calculator, Drug Dose (product code NDC), 2026 Q3: 311 adverse event reports received by the FDA (0 death, 77 injury, 233 malfunction and 1 other). Recent quarter: reports are still arriving.","value":311,"unit":"device adverse event reports received","reports":311,"deaths":0,"injuries":77,"malfunctions":233,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KZI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KZI","deviceName":"Culture Media, Enriched","specialty":"Microbiology","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Culture Media, Enriched (product code KZI), 2026 Q3: 306 adverse event reports received by the FDA (0 death, 0 injury, 306 malfunction and 0 other). Recent quarter: reports are still arriving.","value":306,"unit":"device adverse event reports received","reports":306,"deaths":0,"injuries":0,"malfunctions":306,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FMG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2026 Q3: 300 adverse event reports received by the FDA (0 death, 6 injury, 294 malfunction and 0 other). Recent quarter: reports are still arriving.","value":300,"unit":"device adverse event reports received","reports":300,"deaths":0,"injuries":6,"malfunctions":294,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NKB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2026 Q3: 299 adverse event reports received by the FDA (0 death, 104 injury, 192 malfunction and 3 other). Recent quarter: reports are still arriving.","value":299,"unit":"device adverse event reports received","reports":299,"deaths":0,"injuries":104,"malfunctions":192,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QJP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2026 Q3: 299 adverse event reports received by the FDA (5 death, 34 injury, 260 malfunction and 0 other). Recent quarter: reports are still arriving.","value":299,"unit":"device adverse event reports received","reports":299,"deaths":5,"injuries":34,"malfunctions":260,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PKL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2026 Q3: 298 adverse event reports received by the FDA (7 death, 17 injury, 274 malfunction and 0 other). Recent quarter: reports are still arriving.","value":298,"unit":"device adverse event reports received","reports":298,"deaths":7,"injuries":17,"malfunctions":274,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ONB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2026 Q3: 291 adverse event reports received by the FDA (0 death, 51 injury, 236 malfunction and 4 other). Recent quarter: reports are still arriving.","value":291,"unit":"device adverse event reports received","reports":291,"deaths":0,"injuries":51,"malfunctions":236,"other":4,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KWA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2026 Q3: 287 adverse event reports received by the FDA (0 death, 153 injury, 134 malfunction and 0 other). Recent quarter: reports are still arriving.","value":287,"unit":"device adverse event reports received","reports":287,"deaths":0,"injuries":153,"malfunctions":134,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OZO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2026 Q3: 286 adverse event reports received by the FDA (4 death, 49 injury, 233 malfunction and 0 other). Recent quarter: reports are still arriving.","value":286,"unit":"device adverse event reports received","reports":286,"deaths":4,"injuries":49,"malfunctions":233,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NIM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stent, Carotid (product code NIM), 2026 Q3: 284 adverse event reports received by the FDA (12 death, 60 injury, 209 malfunction and 3 other). Recent quarter: reports are still arriving.","value":284,"unit":"device adverse event reports received","reports":284,"deaths":12,"injuries":60,"malfunctions":209,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DXC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Clamp, Vascular (product code DXC), 2026 Q3: 282 adverse event reports received by the FDA (0 death, 18 injury, 262 malfunction and 2 other). Recent quarter: reports are still arriving.","value":282,"unit":"device adverse event reports received","reports":282,"deaths":0,"injuries":18,"malfunctions":262,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MEB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2026 Q3: 278 adverse event reports received by the FDA (0 death, 7 injury, 269 malfunction and 2 other). Recent quarter: reports are still arriving.","value":278,"unit":"device adverse event reports received","reports":278,"deaths":0,"injuries":7,"malfunctions":269,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KRA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2026 Q3: 270 adverse event reports received by the FDA (12 death, 43 injury, 214 malfunction and 1 other). Recent quarter: reports are still arriving.","value":270,"unit":"device adverse event reports received","reports":270,"deaths":12,"injuries":43,"malfunctions":214,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JXG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2026 Q3: 266 adverse event reports received by the FDA (4 death, 182 injury, 73 malfunction and 7 other). Recent quarter: reports are still arriving.","value":266,"unit":"device adverse event reports received","reports":266,"deaths":4,"injuries":182,"malfunctions":73,"other":7,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LHI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2026 Q3: 266 adverse event reports received by the FDA (0 death, 2 injury, 256 malfunction and 8 other). Recent quarter: reports are still arriving.","value":266,"unit":"device adverse event reports received","reports":266,"deaths":0,"injuries":2,"malfunctions":256,"other":8,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LPB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2026 Q3: 266 adverse event reports received by the FDA (9 death, 106 injury, 151 malfunction and 0 other). Recent quarter: reports are still arriving.","value":266,"unit":"device adverse event reports received","reports":266,"deaths":9,"injuries":106,"malfunctions":151,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DWF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2026 Q3: 261 adverse event reports received by the FDA (3 death, 27 injury, 231 malfunction and 0 other). Recent quarter: reports are still arriving.","value":261,"unit":"device adverse event reports received","reports":261,"deaths":3,"injuries":27,"malfunctions":231,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JOH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2026 Q3: 261 adverse event reports received by the FDA (0 death, 37 injury, 221 malfunction and 3 other). Recent quarter: reports are still arriving.","value":261,"unit":"device adverse event reports received","reports":261,"deaths":0,"injuries":37,"malfunctions":221,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:IZI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2026 Q3: 259 adverse event reports received by the FDA (0 death, 1 injury, 257 malfunction and 1 other). Recent quarter: reports are still arriving.","value":259,"unit":"device adverse event reports received","reports":259,"deaths":0,"injuries":1,"malfunctions":257,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JEY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Plate, Bone (product code JEY), 2026 Q3: 257 adverse event reports received by the FDA (0 death, 29 injury, 228 malfunction and 0 other). Recent quarter: reports are still arriving.","value":257,"unit":"device adverse event reports received","reports":257,"deaths":0,"injuries":29,"malfunctions":228,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HSD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2026 Q3: 255 adverse event reports received by the FDA (0 death, 232 injury, 23 malfunction and 0 other). Recent quarter: reports are still arriving.","value":255,"unit":"device adverse event reports received","reports":255,"deaths":0,"injuries":232,"malfunctions":23,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GBX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Irrigation (product code GBX), 2026 Q3: 250 adverse event reports received by the FDA (0 death, 21 injury, 227 malfunction and 2 other). Recent quarter: reports are still arriving.","value":250,"unit":"device adverse event reports received","reports":250,"deaths":0,"injuries":21,"malfunctions":227,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MNQ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2026 Q3: 249 adverse event reports received by the FDA (0 death, 245 injury, 3 malfunction and 1 other). Recent quarter: reports are still arriving.","value":249,"unit":"device adverse event reports received","reports":249,"deaths":0,"injuries":245,"malfunctions":3,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MFK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2026 Q3: 248 adverse event reports received by the FDA (0 death, 156 injury, 92 malfunction and 0 other). Recent quarter: reports are still arriving.","value":248,"unit":"device adverse event reports received","reports":248,"deaths":0,"injuries":156,"malfunctions":92,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NPS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2026 Q3: 246 adverse event reports received by the FDA (6 death, 148 injury, 90 malfunction and 2 other). Recent quarter: reports are still arriving.","value":246,"unit":"device adverse event reports received","reports":246,"deaths":6,"injuries":148,"malfunctions":90,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GEY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2026 Q3: 245 adverse event reports received by the FDA (0 death, 3 injury, 242 malfunction and 0 other). Recent quarter: reports are still arriving.","value":245,"unit":"device adverse event reports received","reports":245,"deaths":0,"injuries":3,"malfunctions":242,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LFR:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2026 Q3: 240 adverse event reports received by the FDA (0 death, 10 injury, 230 malfunction and 0 other). Recent quarter: reports are still arriving.","value":240,"unit":"device adverse event reports received","reports":240,"deaths":0,"injuries":10,"malfunctions":230,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MCX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2026 Q3: 236 adverse event reports received by the FDA (17 death, 72 injury, 147 malfunction and 0 other). Recent quarter: reports are still arriving.","value":236,"unit":"device adverse event reports received","reports":236,"deaths":17,"injuries":72,"malfunctions":147,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NWX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2026 Q3: 235 adverse event reports received by the FDA (4 death, 40 injury, 191 malfunction and 0 other). Recent quarter: reports are still arriving.","value":235,"unit":"device adverse event reports received","reports":235,"deaths":4,"injuries":40,"malfunctions":191,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:EZC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Coude (product code EZC), 2026 Q3: 234 adverse event reports received by the FDA (0 death, 26 injury, 205 malfunction and 3 other). Recent quarter: reports are still arriving.","value":234,"unit":"device adverse event reports received","reports":234,"deaths":0,"injuries":26,"malfunctions":205,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NJL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2026 Q3: 233 adverse event reports received by the FDA (0 death, 229 injury, 4 malfunction and 0 other). Recent quarter: reports are still arriving.","value":233,"unit":"device adverse event reports received","reports":233,"deaths":0,"injuries":229,"malfunctions":4,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DQO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2026 Q3: 231 adverse event reports received by the FDA (1 death, 21 injury, 203 malfunction and 6 other). Recent quarter: reports are still arriving.","value":231,"unit":"device adverse event reports received","reports":231,"deaths":1,"injuries":21,"malfunctions":203,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MTA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2026 Q3: 230 adverse event reports received by the FDA (0 death, 182 injury, 48 malfunction and 0 other). Recent quarter: reports are still arriving.","value":230,"unit":"device adverse event reports received","reports":230,"deaths":0,"injuries":182,"malfunctions":48,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NJE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2026 Q3: 229 adverse event reports received by the FDA (1 death, 13 injury, 215 malfunction and 0 other). Recent quarter: reports are still arriving.","value":229,"unit":"device adverse event reports received","reports":229,"deaths":1,"injuries":13,"malfunctions":215,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NIP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2026 Q3: 228 adverse event reports received by the FDA (2 death, 107 injury, 119 malfunction and 0 other). Recent quarter: reports are still arriving.","value":228,"unit":"device adverse event reports received","reports":228,"deaths":2,"injuries":107,"malfunctions":119,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ITX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2026 Q3: 225 adverse event reports received by the FDA (0 death, 4 injury, 220 malfunction and 1 other). Recent quarter: reports are still arriving.","value":225,"unit":"device adverse event reports received","reports":225,"deaths":0,"injuries":4,"malfunctions":220,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MCW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2026 Q3: 224 adverse event reports received by the FDA (3 death, 70 injury, 151 malfunction and 0 other). Recent quarter: reports are still arriving.","value":224,"unit":"device adverse event reports received","reports":224,"deaths":3,"injuries":70,"malfunctions":151,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GWF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2026 Q3: 219 adverse event reports received by the FDA (0 death, 2 injury, 216 malfunction and 1 other). Recent quarter: reports are still arriving.","value":219,"unit":"device adverse event reports received","reports":219,"deaths":0,"injuries":2,"malfunctions":216,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OAE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2026 Q3: 218 adverse event reports received by the FDA (7 death, 103 injury, 105 malfunction and 3 other). Recent quarter: reports are still arriving.","value":218,"unit":"device adverse event reports received","reports":218,"deaths":7,"injuries":103,"malfunctions":105,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LON:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2026 Q3: 212 adverse event reports received by the FDA (0 death, 0 injury, 212 malfunction and 0 other). Recent quarter: reports are still arriving.","value":212,"unit":"device adverse event reports received","reports":212,"deaths":0,"injuries":0,"malfunctions":212,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DXF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Septostomy (product code DXF), 2026 Q3: 211 adverse event reports received by the FDA (10 death, 148 injury, 51 malfunction and 2 other). Recent quarter: reports are still arriving.","value":211,"unit":"device adverse event reports received","reports":211,"deaths":10,"injuries":148,"malfunctions":51,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:CAW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2026 Q3: 206 adverse event reports received by the FDA (7 death, 134 injury, 63 malfunction and 2 other). Recent quarter: reports are still arriving.","value":206,"unit":"device adverse event reports received","reports":206,"deaths":7,"injuries":134,"malfunctions":63,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GFD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Dermatome (product code GFD), 2026 Q3: 205 adverse event reports received by the FDA (0 death, 4 injury, 200 malfunction and 1 other). Recent quarter: reports are still arriving.","value":205,"unit":"device adverse event reports received","reports":205,"deaths":0,"injuries":4,"malfunctions":200,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DXY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2026 Q3: 204 adverse event reports received by the FDA (15 death, 73 injury, 115 malfunction and 1 other). Recent quarter: reports are still arriving.","value":204,"unit":"device adverse event reports received","reports":204,"deaths":15,"injuries":73,"malfunctions":115,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MND:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ligator, Esophageal (product code MND), 2026 Q3: 204 adverse event reports received by the FDA (0 death, 22 injury, 182 malfunction and 0 other). Recent quarter: reports are still arriving.","value":204,"unit":"device adverse event reports received","reports":204,"deaths":0,"injuries":22,"malfunctions":182,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PFO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2026 Q3: 197 adverse event reports received by the FDA (0 death, 183 injury, 13 malfunction and 1 other). Recent quarter: reports are still arriving.","value":197,"unit":"device adverse event reports received","reports":197,"deaths":0,"injuries":183,"malfunctions":13,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MLV:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2026 Q3: 195 adverse event reports received by the FDA (5 death, 75 injury, 114 malfunction and 1 other). Recent quarter: reports are still arriving.","value":195,"unit":"device adverse event reports received","reports":195,"deaths":5,"injuries":75,"malfunctions":114,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KRO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2026 Q3: 193 adverse event reports received by the FDA (7 death, 180 injury, 5 malfunction and 1 other). Recent quarter: reports are still arriving.","value":193,"unit":"device adverse event reports received","reports":193,"deaths":7,"injuries":180,"malfunctions":5,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OCW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2026 Q3: 192 adverse event reports received by the FDA (1 death, 52 injury, 138 malfunction and 1 other). Recent quarter: reports are still arriving.","value":192,"unit":"device adverse event reports received","reports":192,"deaths":1,"injuries":52,"malfunctions":138,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OOK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2026 Q3: 192 adverse event reports received by the FDA (0 death, 192 injury, 0 malfunction and 0 other). Recent quarter: reports are still arriving.","value":192,"unit":"device adverse event reports received","reports":192,"deaths":0,"injuries":192,"malfunctions":0,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FPO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stretcher, Wheeled (product code FPO), 2026 Q3: 187 adverse event reports received by the FDA (2 death, 11 injury, 174 malfunction and 0 other). Recent quarter: reports are still arriving.","value":187,"unit":"device adverse event reports received","reports":187,"deaths":2,"injuries":11,"malfunctions":174,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KRG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Programmer, Pacemaker (product code KRG), 2026 Q3: 185 adverse event reports received by the FDA (0 death, 4 injury, 181 malfunction and 0 other). Recent quarter: reports are still arriving.","value":185,"unit":"device adverse event reports received","reports":185,"deaths":0,"injuries":4,"malfunctions":181,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GZF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2026 Q3: 184 adverse event reports received by the FDA (3 death, 138 injury, 43 malfunction and 0 other). Recent quarter: reports are still arriving.","value":184,"unit":"device adverse event reports received","reports":184,"deaths":3,"injuries":138,"malfunctions":43,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MAX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2026 Q3: 180 adverse event reports received by the FDA (0 death, 28 injury, 149 malfunction and 3 other). Recent quarter: reports are still arriving.","value":180,"unit":"device adverse event reports received","reports":180,"deaths":0,"injuries":28,"malfunctions":149,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HNN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Knife, Ophthalmic (product code HNN), 2026 Q3: 175 adverse event reports received by the FDA (0 death, 7 injury, 168 malfunction and 0 other). Recent quarter: reports are still arriving.","value":175,"unit":"device adverse event reports received","reports":175,"deaths":0,"injuries":7,"malfunctions":168,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PRL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2026 Q3: 172 adverse event reports received by the FDA (1 death, 81 injury, 88 malfunction and 2 other). Recent quarter: reports are still arriving.","value":172,"unit":"device adverse event reports received","reports":172,"deaths":1,"injuries":81,"malfunctions":88,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FFT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2026 Q3: 164 adverse event reports received by the FDA (0 death, 47 injury, 111 malfunction and 6 other). Recent quarter: reports are still arriving.","value":164,"unit":"device adverse event reports received","reports":164,"deaths":0,"injuries":47,"malfunctions":111,"other":6,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NSA:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2026 Q3: 160 adverse event reports received by the FDA (3 death, 1 injury, 156 malfunction and 0 other). Recent quarter: reports are still arriving.","value":160,"unit":"device adverse event reports received","reports":160,"deaths":3,"injuries":1,"malfunctions":156,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DQK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2026 Q3: 156 adverse event reports received by the FDA (0 death, 14 injury, 139 malfunction and 3 other). Recent quarter: reports are still arriving.","value":156,"unit":"device adverse event reports received","reports":156,"deaths":0,"injuries":14,"malfunctions":139,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NXC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Aligner, Sequential (product code NXC), 2026 Q3: 156 adverse event reports received by the FDA (0 death, 150 injury, 5 malfunction and 1 other). Recent quarter: reports are still arriving.","value":156,"unit":"device adverse event reports received","reports":156,"deaths":0,"injuries":150,"malfunctions":5,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:POE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2026 Q3: 156 adverse event reports received by the FDA (0 death, 82 injury, 74 malfunction and 0 other). Recent quarter: reports are still arriving.","value":156,"unit":"device adverse event reports received","reports":156,"deaths":0,"injuries":82,"malfunctions":74,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KWP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2026 Q3: 155 adverse event reports received by the FDA (0 death, 59 injury, 96 malfunction and 0 other). Recent quarter: reports are still arriving.","value":155,"unit":"device adverse event reports received","reports":155,"deaths":0,"injuries":59,"malfunctions":96,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GDO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2026 Q3: 153 adverse event reports received by the FDA (0 death, 2 injury, 151 malfunction and 0 other). Recent quarter: reports are still arriving.","value":153,"unit":"device adverse event reports received","reports":153,"deaths":0,"injuries":2,"malfunctions":151,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GCT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2026 Q3: 151 adverse event reports received by the FDA (0 death, 0 injury, 151 malfunction and 0 other). Recent quarter: reports are still arriving.","value":151,"unit":"device adverse event reports received","reports":151,"deaths":0,"injuries":0,"malfunctions":151,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FCG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Biopsy Needle (product code FCG), 2026 Q3: 149 adverse event reports received by the FDA (0 death, 12 injury, 136 malfunction and 1 other). Recent quarter: reports are still arriving.","value":149,"unit":"device adverse event reports received","reports":149,"deaths":0,"injuries":12,"malfunctions":136,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FAD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stent, Ureteral (product code FAD), 2026 Q3: 147 adverse event reports received by the FDA (0 death, 37 injury, 107 malfunction and 3 other). Recent quarter: reports are still arriving.","value":147,"unit":"device adverse event reports received","reports":147,"deaths":0,"injuries":37,"malfunctions":107,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NBH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2026 Q3: 146 adverse event reports received by the FDA (0 death, 7 injury, 138 malfunction and 1 other). Recent quarter: reports are still arriving.","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":7,"malfunctions":138,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NPW:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2026 Q3: 141 adverse event reports received by the FDA (7 death, 128 injury, 6 malfunction and 0 other). Recent quarter: reports are still arriving.","value":141,"unit":"device adverse event reports received","reports":141,"deaths":7,"injuries":128,"malfunctions":6,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DTE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2026 Q3: 140 adverse event reports received by the FDA (2 death, 7 injury, 130 malfunction and 1 other). Recent quarter: reports are still arriving.","value":140,"unit":"device adverse event reports received","reports":140,"deaths":2,"injuries":7,"malfunctions":130,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:JEQ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Toothbrush, Powered (product code JEQ), 2026 Q3: 140 adverse event reports received by the FDA (0 death, 10 injury, 130 malfunction and 0 other). Recent quarter: reports are still arriving.","value":140,"unit":"device adverse event reports received","reports":140,"deaths":0,"injuries":10,"malfunctions":130,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NIO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stent, Iliac (product code NIO), 2026 Q3: 140 adverse event reports received by the FDA (4 death, 68 injury, 68 malfunction and 0 other). Recent quarter: reports are still arriving.","value":140,"unit":"device adverse event reports received","reports":140,"deaths":4,"injuries":68,"malfunctions":68,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DWC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2026 Q3: 139 adverse event reports received by the FDA (0 death, 3 injury, 135 malfunction and 1 other). Recent quarter: reports are still arriving.","value":139,"unit":"device adverse event reports received","reports":139,"deaths":0,"injuries":3,"malfunctions":135,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KWT:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2026 Q3: 139 adverse event reports received by the FDA (0 death, 132 injury, 7 malfunction and 0 other). Recent quarter: reports are still arriving.","value":139,"unit":"device adverse event reports received","reports":139,"deaths":0,"injuries":132,"malfunctions":7,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HTO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Reamer (product code HTO), 2026 Q3: 135 adverse event reports received by the FDA (0 death, 6 injury, 129 malfunction and 0 other). Recent quarter: reports are still arriving.","value":135,"unit":"device adverse event reports received","reports":135,"deaths":0,"injuries":6,"malfunctions":129,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GCM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Endoscope, Rigid (product code GCM), 2026 Q3: 133 adverse event reports received by the FDA (0 death, 1 injury, 132 malfunction and 0 other). Recent quarter: reports are still arriving.","value":133,"unit":"device adverse event reports received","reports":133,"deaths":0,"injuries":1,"malfunctions":132,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HEB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2026 Q3: 131 adverse event reports received by the FDA (0 death, 63 injury, 63 malfunction and 5 other). Recent quarter: reports are still arriving.","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":63,"malfunctions":63,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:IYO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2026 Q3: 131 adverse event reports received by the FDA (0 death, 2 injury, 129 malfunction and 0 other). Recent quarter: reports are still arriving.","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":2,"malfunctions":129,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ETN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Stimulator, Nerve (product code ETN), 2026 Q3: 130 adverse event reports received by the FDA (0 death, 16 injury, 113 malfunction and 1 other). Recent quarter: reports are still arriving.","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":16,"malfunctions":113,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HCG:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2026 Q3: 129 adverse event reports received by the FDA (0 death, 36 injury, 92 malfunction and 1 other). Recent quarter: reports are still arriving.","value":129,"unit":"device adverse event reports received","reports":129,"deaths":0,"injuries":36,"malfunctions":92,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NDN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2026 Q3: 126 adverse event reports received by the FDA (0 death, 8 injury, 117 malfunction and 1 other). Recent quarter: reports are still arriving.","value":126,"unit":"device adverse event reports received","reports":126,"deaths":0,"injuries":8,"malfunctions":117,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ONU:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2026 Q3: 125 adverse event reports received by the FDA (1 death, 86 injury, 38 malfunction and 0 other). Recent quarter: reports are still arriving.","value":125,"unit":"device adverse event reports received","reports":125,"deaths":1,"injuries":86,"malfunctions":38,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GIM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2026 Q3: 124 adverse event reports received by the FDA (0 death, 1 injury, 122 malfunction and 1 other). Recent quarter: reports are still arriving.","value":124,"unit":"device adverse event reports received","reports":124,"deaths":0,"injuries":1,"malfunctions":122,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FQH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Lavage, Jet (product code FQH), 2026 Q3: 123 adverse event reports received by the FDA (0 death, 3 injury, 115 malfunction and 5 other). Recent quarter: reports are still arriving.","value":123,"unit":"device adverse event reports received","reports":123,"deaths":0,"injuries":3,"malfunctions":115,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PNO:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2026 Q3: 123 adverse event reports received by the FDA (0 death, 7 injury, 116 malfunction and 0 other). Recent quarter: reports are still arriving.","value":123,"unit":"device adverse event reports received","reports":123,"deaths":0,"injuries":7,"malfunctions":116,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LNH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2026 Q3: 120 adverse event reports received by the FDA (0 death, 52 injury, 63 malfunction and 5 other). Recent quarter: reports are still arriving.","value":120,"unit":"device adverse event reports received","reports":120,"deaths":0,"injuries":52,"malfunctions":63,"other":5,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FZX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2026 Q3: 118 adverse event reports received by the FDA (0 death, 9 injury, 109 malfunction and 0 other). Recent quarter: reports are still arriving.","value":118,"unit":"device adverse event reports received","reports":118,"deaths":0,"injuries":9,"malfunctions":109,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:NRY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2026 Q3: 116 adverse event reports received by the FDA (9 death, 26 injury, 80 malfunction and 1 other). Recent quarter: reports are still arriving.","value":116,"unit":"device adverse event reports received","reports":116,"deaths":9,"injuries":26,"malfunctions":80,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QHJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2026 Q3: 114 adverse event reports received by the FDA (0 death, 23 injury, 90 malfunction and 1 other). Recent quarter: reports are still arriving.","value":114,"unit":"device adverse event reports received","reports":114,"deaths":0,"injuries":23,"malfunctions":90,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OOI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2026 Q3: 113 adverse event reports received by the FDA (0 death, 2 injury, 111 malfunction and 0 other). Recent quarter: reports are still arriving.","value":113,"unit":"device adverse event reports received","reports":113,"deaths":0,"injuries":2,"malfunctions":111,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MDB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Blood Culturing (product code MDB), 2026 Q3: 112 adverse event reports received by the FDA (0 death, 0 injury, 112 malfunction and 0 other). Recent quarter: reports are still arriving.","value":112,"unit":"device adverse event reports received","reports":112,"deaths":0,"injuries":0,"malfunctions":112,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HAB:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2026 Q3: 110 adverse event reports received by the FDA (0 death, 1 injury, 108 malfunction and 1 other). Recent quarter: reports are still arriving.","value":110,"unit":"device adverse event reports received","reports":110,"deaths":0,"injuries":1,"malfunctions":108,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:IYN:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2026 Q3: 107 adverse event reports received by the FDA (0 death, 20 injury, 87 malfunction and 0 other). Recent quarter: reports are still arriving.","value":107,"unit":"device adverse event reports received","reports":107,"deaths":0,"injuries":20,"malfunctions":87,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PZK:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2026 Q3: 107 adverse event reports received by the FDA (0 death, 105 injury, 1 malfunction and 1 other). Recent quarter: reports are still arriving.","value":107,"unit":"device adverse event reports received","reports":107,"deaths":0,"injuries":105,"malfunctions":1,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MAH:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2026 Q3: 106 adverse event reports received by the FDA (0 death, 106 injury, 0 malfunction and 0 other). Recent quarter: reports are still arriving.","value":106,"unit":"device adverse event reports received","reports":106,"deaths":0,"injuries":106,"malfunctions":0,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MRM:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2026 Q3: 103 adverse event reports received by the FDA (2 death, 60 injury, 41 malfunction and 0 other). Recent quarter: reports are still arriving.","value":103,"unit":"device adverse event reports received","reports":103,"deaths":2,"injuries":60,"malfunctions":41,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PYX:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2026 Q3: 101 adverse event reports received by the FDA (19 death, 48 injury, 34 malfunction and 0 other). Recent quarter: reports are still arriving.","value":101,"unit":"device adverse event reports received","reports":101,"deaths":19,"injuries":48,"malfunctions":34,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:GAP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2026 Q3: 97 adverse event reports received by the FDA (0 death, 13 injury, 84 malfunction and 0 other). Recent quarter: reports are still arriving.","value":97,"unit":"device adverse event reports received","reports":97,"deaths":0,"injuries":13,"malfunctions":84,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:ITI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Wheelchair, Powered (product code ITI), 2026 Q3: 95 adverse event reports received by the FDA (0 death, 45 injury, 47 malfunction and 3 other). Recent quarter: reports are still arriving.","value":95,"unit":"device adverse event reports received","reports":95,"deaths":0,"injuries":45,"malfunctions":47,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MSD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2026 Q3: 93 adverse event reports received by the FDA (0 death, 13 injury, 79 malfunction and 1 other). Recent quarter: reports are still arriving.","value":93,"unit":"device adverse event reports received","reports":93,"deaths":0,"injuries":13,"malfunctions":79,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DSI:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2026 Q3: 92 adverse event reports received by the FDA (3 death, 9 injury, 79 malfunction and 1 other). Recent quarter: reports are still arriving.","value":92,"unit":"device adverse event reports received","reports":92,"deaths":3,"injuries":9,"malfunctions":79,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:LCJ:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2026 Q3: 92 adverse event reports received by the FDA (0 death, 73 injury, 19 malfunction and 0 other). Recent quarter: reports are still arriving.","value":92,"unit":"device adverse event reports received","reports":92,"deaths":0,"injuries":73,"malfunctions":19,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:OOE:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2026 Q3: 90 adverse event reports received by the FDA (0 death, 37 injury, 52 malfunction and 1 other). Recent quarter: reports are still arriving.","value":90,"unit":"device adverse event reports received","reports":90,"deaths":0,"injuries":37,"malfunctions":52,"other":1,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FFL:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2026 Q3: 89 adverse event reports received by the FDA (0 death, 4 injury, 83 malfunction and 2 other). Recent quarter: reports are still arriving.","value":89,"unit":"device adverse event reports received","reports":89,"deaths":0,"injuries":4,"malfunctions":83,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MSS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2026 Q3: 78 adverse event reports received by the FDA (0 death, 20 injury, 58 malfunction and 0 other). Recent quarter: reports are still arriving.","value":78,"unit":"device adverse event reports received","reports":78,"deaths":0,"injuries":20,"malfunctions":58,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DRF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2026 Q3: 73 adverse event reports received by the FDA (4 death, 32 injury, 35 malfunction and 2 other). Recent quarter: reports are still arriving.","value":73,"unit":"device adverse event reports received","reports":73,"deaths":4,"injuries":32,"malfunctions":35,"other":2,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:MZF:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Test, Hiv Detection (product code MZF), 2026 Q3: 73 adverse event reports received by the FDA (0 death, 0 injury, 73 malfunction and 0 other). Recent quarter: reports are still arriving.","value":73,"unit":"device adverse event reports received","reports":73,"deaths":0,"injuries":0,"malfunctions":73,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:QKP:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2026 Q3: 69 adverse event reports received by the FDA (0 death, 0 injury, 69 malfunction and 0 other). Recent quarter: reports are still arriving.","value":69,"unit":"device adverse event reports received","reports":69,"deaths":0,"injuries":0,"malfunctions":69,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:HHS:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2026 Q3: 66 adverse event reports received by the FDA (0 death, 63 injury, 0 malfunction and 3 other). Recent quarter: reports are still arriving.","value":66,"unit":"device adverse event reports received","reports":66,"deaths":0,"injuries":63,"malfunctions":0,"other":3,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:CAD:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2026 Q3: 62 adverse event reports received by the FDA (0 death, 2 injury, 60 malfunction and 0 other). Recent quarter: reports are still arriving.","value":62,"unit":"device adverse event reports received","reports":62,"deaths":0,"injuries":2,"malfunctions":60,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:PKU:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2026 Q3: 62 adverse event reports received by the FDA (0 death, 0 injury, 62 malfunction and 0 other). Recent quarter: reports are still arriving.","value":62,"unit":"device adverse event reports received","reports":62,"deaths":0,"injuries":0,"malfunctions":62,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:KMY:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2026 Q3: 35 adverse event reports received by the FDA (0 death, 34 injury, 1 malfunction and 0 other). Recent quarter: reports are still arriving.","value":35,"unit":"device adverse event reports received","reports":35,"deaths":0,"injuries":34,"malfunctions":1,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:FGC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Urethroscope (product code FGC), 2026 Q3: 15 adverse event reports received by the FDA (0 death, 0 injury, 15 malfunction and 0 other). Recent quarter: reports are still arriving.","value":15,"unit":"device adverse event reports received","reports":15,"deaths":0,"injuries":0,"malfunctions":15,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DTC:2026Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTC","deviceName":"Analyzer, Pacemaker Generator Function","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q3","year":2026,"qtr":3,"periodStart":"2026-07-01","periodEnd":"2026-09-30","status":"P","text":"Analyzer, Pacemaker Generator Function (product code DTC), 2026 Q3: 12 adverse event reports received by the FDA (0 death, 0 injury, 12 malfunction and 0 other). Recent quarter: reports are still arriving.","value":12,"unit":"device adverse event reports received","reports":12,"deaths":0,"injuries":0,"malfunctions":12,"other":0,"effectiveFrom":"2026-07-01","effectiveTo":"2026-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":true,"moe":null},"lastChecked":"2026-10-29","confidence":"medium","confidenceBasis":"preliminary figure"},{"id":"device-events:DZE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2026 Q2: 190,652 adverse event reports received by the FDA (2 death, 190,267 injury, 383 malfunction and 0 other).","value":190652,"unit":"device adverse event reports received","reports":190652,"deaths":2,"injuries":190267,"malfunctions":383,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2026 Q2: 181,237 adverse event reports received by the FDA (27 death, 5,416 injury, 175,794 malfunction and 0 other).","value":181237,"unit":"device adverse event reports received","reports":181237,"deaths":27,"injuries":5416,"malfunctions":175794,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QFG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2026 Q2: 100,276 adverse event reports received by the FDA (54 death, 14,570 injury, 85,652 malfunction and 0 other).","value":100276,"unit":"device adverse event reports received","reports":100276,"deaths":54,"injuries":14570,"malfunctions":85652,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2026 Q2: 63,543 adverse event reports received by the FDA (320 death, 24,745 injury, 38,470 malfunction and 8 other).","value":63543,"unit":"device adverse event reports received","reports":63543,"deaths":320,"injuries":24745,"malfunctions":38470,"other":8,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2026 Q2: 26,536 adverse event reports received by the FDA (19 death, 2,788 injury, 23,729 malfunction and 0 other).","value":26536,"unit":"device adverse event reports received","reports":26536,"deaths":19,"injuries":2788,"malfunctions":23729,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2026 Q2: 23,466 adverse event reports received by the FDA (0 death, 6 injury, 23,460 malfunction and 0 other).","value":23466,"unit":"device adverse event reports received","reports":23466,"deaths":0,"injuries":6,"malfunctions":23460,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BZD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2026 Q2: 16,531 adverse event reports received by the FDA (9 death, 51 injury, 16,471 malfunction and 0 other).","value":16531,"unit":"device adverse event reports received","reports":16531,"deaths":9,"injuries":51,"malfunctions":16471,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BRY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2026 Q2: 15,355 adverse event reports received by the FDA (1 death, 2 injury, 15,352 malfunction and 0 other).","value":15355,"unit":"device adverse event reports received","reports":15355,"deaths":1,"injuries":2,"malfunctions":15352,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FRN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pump, Infusion (product code FRN), 2026 Q2: 14,336 adverse event reports received by the FDA (24 death, 169 injury, 14,141 malfunction and 2 other).","value":14336,"unit":"device adverse event reports received","reports":14336,"deaths":24,"injuries":169,"malfunctions":14141,"other":2,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2026 Q2: 10,254 adverse event reports received by the FDA (0 death, 19 injury, 10,235 malfunction and 0 other).","value":10254,"unit":"device adverse event reports received","reports":10254,"deaths":0,"injuries":19,"malfunctions":10235,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2026 Q2: 10,195 adverse event reports received by the FDA (0 death, 21 injury, 10,174 malfunction and 0 other).","value":10195,"unit":"device adverse event reports received","reports":10195,"deaths":0,"injuries":21,"malfunctions":10174,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2026 Q2: 10,146 adverse event reports received by the FDA (22 death, 504 injury, 9,620 malfunction and 0 other).","value":10146,"unit":"device adverse event reports received","reports":10146,"deaths":22,"injuries":504,"malfunctions":9620,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2026 Q2: 8,699 adverse event reports received by the FDA (1 death, 8,580 injury, 115 malfunction and 3 other).","value":8699,"unit":"device adverse event reports received","reports":8699,"deaths":1,"injuries":8580,"malfunctions":115,"other":3,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LGW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2026 Q2: 8,195 adverse event reports received by the FDA (68 death, 6,403 injury, 1,721 malfunction and 3 other).","value":8195,"unit":"device adverse event reports received","reports":8195,"deaths":68,"injuries":6403,"malfunctions":1721,"other":3,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QLG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2026 Q2: 7,749 adverse event reports received by the FDA (1 death, 750 injury, 6,998 malfunction and 0 other).","value":7749,"unit":"device adverse event reports received","reports":7749,"deaths":1,"injuries":750,"malfunctions":6998,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2026 Q2: 7,086 adverse event reports received by the FDA (55 death, 2,660 injury, 4,371 malfunction and 0 other).","value":7086,"unit":"device adverse event reports received","reports":7086,"deaths":55,"injuries":2660,"malfunctions":4371,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2026 Q2: 6,073 adverse event reports received by the FDA (64 death, 3,386 injury, 2,623 malfunction and 0 other).","value":6073,"unit":"device adverse event reports received","reports":6073,"deaths":64,"injuries":3386,"malfunctions":2623,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2026 Q2: 5,900 adverse event reports received by the FDA (55 death, 3,208 injury, 2,637 malfunction and 0 other).","value":5900,"unit":"device adverse event reports received","reports":5900,"deaths":55,"injuries":3208,"malfunctions":2637,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2026 Q2: 5,222 adverse event reports received by the FDA (25 death, 1,666 injury, 3,531 malfunction and 0 other).","value":5222,"unit":"device adverse event reports received","reports":5222,"deaths":25,"injuries":1666,"malfunctions":3531,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FET:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2026 Q2: 5,085 adverse event reports received by the FDA (0 death, 12 injury, 5,073 malfunction and 0 other).","value":5085,"unit":"device adverse event reports received","reports":5085,"deaths":0,"injuries":12,"malfunctions":5073,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PQF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2026 Q2: 4,980 adverse event reports received by the FDA (0 death, 13 injury, 4,967 malfunction and 0 other).","value":4980,"unit":"device adverse event reports received","reports":4980,"deaths":0,"injuries":13,"malfunctions":4967,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CBK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2026 Q2: 4,213 adverse event reports received by the FDA (19 death, 68 injury, 4,126 malfunction and 0 other).","value":4213,"unit":"device adverse event reports received","reports":4213,"deaths":19,"injuries":68,"malfunctions":4126,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2026 Q2: 3,559 adverse event reports received by the FDA (478 death, 1,299 injury, 1,782 malfunction and 0 other).","value":3559,"unit":"device adverse event reports received","reports":3559,"deaths":478,"injuries":1299,"malfunctions":1782,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2026 Q2: 3,237 adverse event reports received by the FDA (246 death, 2,296 injury, 695 malfunction and 0 other).","value":3237,"unit":"device adverse event reports received","reports":3237,"deaths":246,"injuries":2296,"malfunctions":695,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MVK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2026 Q2: 3,122 adverse event reports received by the FDA (48 death, 893 injury, 2,181 malfunction and 0 other).","value":3122,"unit":"device adverse event reports received","reports":3122,"deaths":48,"injuries":893,"malfunctions":2181,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2026 Q2: 3,018 adverse event reports received by the FDA (0 death, 4 injury, 3,014 malfunction and 0 other).","value":3018,"unit":"device adverse event reports received","reports":3018,"deaths":0,"injuries":4,"malfunctions":3014,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2026 Q2: 3,007 adverse event reports received by the FDA (2 death, 47 injury, 2,958 malfunction and 0 other).","value":3007,"unit":"device adverse event reports received","reports":3007,"deaths":2,"injuries":47,"malfunctions":2958,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2026 Q2: 2,922 adverse event reports received by the FDA (34 death, 1,582 injury, 1,304 malfunction and 2 other).","value":2922,"unit":"device adverse event reports received","reports":2922,"deaths":34,"injuries":1582,"malfunctions":1304,"other":2,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MKJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2026 Q2: 2,894 adverse event reports received by the FDA (30 death, 52 injury, 2,812 malfunction and 0 other).","value":2894,"unit":"device adverse event reports received","reports":2894,"deaths":30,"injuries":52,"malfunctions":2812,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Staple, Implantable (product code GDW), 2026 Q2: 2,846 adverse event reports received by the FDA (8 death, 403 injury, 2,435 malfunction and 0 other).","value":2846,"unit":"device adverse event reports received","reports":2846,"deaths":8,"injuries":403,"malfunctions":2435,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOQ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2026 Q2: 2,796 adverse event reports received by the FDA (10 death, 253 injury, 2,533 malfunction and 0 other).","value":2796,"unit":"device adverse event reports received","reports":2796,"deaths":10,"injuries":253,"malfunctions":2533,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2026 Q2: 2,728 adverse event reports received by the FDA (50 death, 1,047 injury, 1,631 malfunction and 0 other).","value":2728,"unit":"device adverse event reports received","reports":2728,"deaths":50,"injuries":1047,"malfunctions":1631,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2026 Q2: 2,653 adverse event reports received by the FDA (2 death, 160 injury, 2,491 malfunction and 0 other).","value":2653,"unit":"device adverse event reports received","reports":2653,"deaths":2,"injuries":160,"malfunctions":2491,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FWM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2026 Q2: 2,603 adverse event reports received by the FDA (1 death, 2,580 injury, 22 malfunction and 0 other).","value":2603,"unit":"device adverse event reports received","reports":2603,"deaths":1,"injuries":2580,"malfunctions":22,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ODG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2026 Q2: 2,555 adverse event reports received by the FDA (0 death, 1 injury, 2,554 malfunction and 0 other).","value":2555,"unit":"device adverse event reports received","reports":2555,"deaths":0,"injuries":1,"malfunctions":2554,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSQ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2026 Q2: 2,496 adverse event reports received by the FDA (415 death, 846 injury, 1,235 malfunction and 0 other).","value":2496,"unit":"device adverse event reports received","reports":2496,"deaths":415,"injuries":846,"malfunctions":1235,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2026 Q2: 2,262 adverse event reports received by the FDA (2 death, 285 injury, 1,975 malfunction and 0 other).","value":2262,"unit":"device adverse event reports received","reports":2262,"deaths":2,"injuries":285,"malfunctions":1975,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JWH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2026 Q2: 2,184 adverse event reports received by the FDA (1 death, 2,021 injury, 161 malfunction and 1 other).","value":2184,"unit":"device adverse event reports received","reports":2184,"deaths":1,"injuries":2021,"malfunctions":161,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2026 Q2: 2,179 adverse event reports received by the FDA (0 death, 11 injury, 2,168 malfunction and 0 other).","value":2179,"unit":"device adverse event reports received","reports":2179,"deaths":0,"injuries":11,"malfunctions":2168,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OYC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2026 Q2: 2,122 adverse event reports received by the FDA (1 death, 14 injury, 2,107 malfunction and 0 other).","value":2122,"unit":"device adverse event reports received","reports":2122,"deaths":1,"injuries":14,"malfunctions":2107,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BSZ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2026 Q2: 2,095 adverse event reports received by the FDA (4 death, 11 injury, 2,080 malfunction and 0 other).","value":2095,"unit":"device adverse event reports received","reports":2095,"deaths":4,"injuries":11,"malfunctions":2080,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2026 Q2: 2,035 adverse event reports received by the FDA (5 death, 18 injury, 2,008 malfunction and 4 other).","value":2035,"unit":"device adverse event reports received","reports":2035,"deaths":5,"injuries":18,"malfunctions":2008,"other":4,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJI","deviceName":"Interoperable Automated Glycemic Controller","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Interoperable Automated Glycemic Controller (product code QJI), 2026 Q2: 1,935 adverse event reports received by the FDA (1 death, 586 injury, 1,348 malfunction and 0 other).","value":1935,"unit":"device adverse event reports received","reports":1935,"deaths":1,"injuries":586,"malfunctions":1348,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2026 Q2: 1,845 adverse event reports received by the FDA (8 death, 273 injury, 1,564 malfunction and 0 other).","value":1845,"unit":"device adverse event reports received","reports":1845,"deaths":8,"injuries":273,"malfunctions":1564,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"General Surgery Tray (product code LRO), 2026 Q2: 1,753 adverse event reports received by the FDA (0 death, 46 injury, 1,707 malfunction and 0 other).","value":1753,"unit":"device adverse event reports received","reports":1753,"deaths":0,"injuries":46,"malfunctions":1707,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2026 Q2: 1,715 adverse event reports received by the FDA (4 death, 99 injury, 1,612 malfunction and 0 other).","value":1715,"unit":"device adverse event reports received","reports":1715,"deaths":4,"injuries":99,"malfunctions":1612,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2026 Q2: 1,643 adverse event reports received by the FDA (0 death, 815 injury, 827 malfunction and 1 other).","value":1643,"unit":"device adverse event reports received","reports":1643,"deaths":0,"injuries":815,"malfunctions":827,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MGB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2026 Q2: 1,571 adverse event reports received by the FDA (6 death, 325 injury, 1,239 malfunction and 1 other).","value":1571,"unit":"device adverse event reports received","reports":1571,"deaths":6,"injuries":325,"malfunctions":1239,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QZI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2026 Q2: 1,523 adverse event reports received by the FDA (27 death, 823 injury, 673 malfunction and 0 other).","value":1523,"unit":"device adverse event reports received","reports":1523,"deaths":27,"injuries":823,"malfunctions":673,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SFI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SFI","deviceName":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System (product code SFI), 2026 Q2: 1,504 adverse event reports received by the FDA (0 death, 26 injury, 1,478 malfunction and 0 other).","value":1504,"unit":"device adverse event reports received","reports":1504,"deaths":0,"injuries":26,"malfunctions":1478,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Leadless Pacemaker (product code PNJ), 2026 Q2: 1,503 adverse event reports received by the FDA (61 death, 533 injury, 909 malfunction and 0 other).","value":1503,"unit":"device adverse event reports received","reports":1503,"deaths":61,"injuries":533,"malfunctions":909,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JKA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2026 Q2: 1,485 adverse event reports received by the FDA (0 death, 17 injury, 1,468 malfunction and 0 other).","value":1485,"unit":"device adverse event reports received","reports":1485,"deaths":0,"injuries":17,"malfunctions":1468,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Intraocular Lens (product code HQL), 2026 Q2: 1,456 adverse event reports received by the FDA (0 death, 344 injury, 1,112 malfunction and 0 other).","value":1456,"unit":"device adverse event reports received","reports":1456,"deaths":0,"injuries":344,"malfunctions":1112,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVZ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2026 Q2: 1,456 adverse event reports received by the FDA (25 death, 741 injury, 690 malfunction and 0 other).","value":1456,"unit":"device adverse event reports received","reports":1456,"deaths":25,"injuries":741,"malfunctions":690,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LKK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2026 Q2: 1,439 adverse event reports received by the FDA (2 death, 584 injury, 853 malfunction and 0 other).","value":1439,"unit":"device adverse event reports received","reports":1439,"deaths":2,"injuries":584,"malfunctions":853,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2026 Q2: 1,417 adverse event reports received by the FDA (5 death, 1,259 injury, 153 malfunction and 0 other).","value":1417,"unit":"device adverse event reports received","reports":1417,"deaths":5,"injuries":1259,"malfunctions":153,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2026 Q2: 1,396 adverse event reports received by the FDA (0 death, 59 injury, 1,337 malfunction and 0 other).","value":1396,"unit":"device adverse event reports received","reports":1396,"deaths":0,"injuries":59,"malfunctions":1337,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Introducer, Catheter (product code DYB), 2026 Q2: 1,333 adverse event reports received by the FDA (54 death, 361 injury, 918 malfunction and 0 other).","value":1333,"unit":"device adverse event reports received","reports":1333,"deaths":54,"injuries":361,"malfunctions":918,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HET:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2026 Q2: 1,315 adverse event reports received by the FDA (0 death, 0 injury, 1,315 malfunction and 0 other).","value":1315,"unit":"device adverse event reports received","reports":1315,"deaths":0,"injuries":0,"malfunctions":1315,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Implant, Cochlear (product code MCM), 2026 Q2: 1,301 adverse event reports received by the FDA (0 death, 832 injury, 469 malfunction and 0 other).","value":1301,"unit":"device adverse event reports received","reports":1301,"deaths":0,"injuries":832,"malfunctions":469,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2026 Q2: 1,295 adverse event reports received by the FDA (31 death, 258 injury, 1,006 malfunction and 0 other).","value":1295,"unit":"device adverse event reports received","reports":1295,"deaths":31,"injuries":258,"malfunctions":1006,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PSV:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2026 Q2: 1,279 adverse event reports received by the FDA (0 death, 27 injury, 1,252 malfunction and 0 other).","value":1279,"unit":"device adverse event reports received","reports":1279,"deaths":0,"injuries":27,"malfunctions":1252,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JJE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2026 Q2: 1,219 adverse event reports received by the FDA (0 death, 22 injury, 1,197 malfunction and 0 other).","value":1219,"unit":"device adverse event reports received","reports":1219,"deaths":0,"injuries":22,"malfunctions":1197,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2026 Q2: 1,198 adverse event reports received by the FDA (1 death, 51 injury, 1,144 malfunction and 2 other).","value":1198,"unit":"device adverse event reports received","reports":1198,"deaths":1,"injuries":51,"malfunctions":1144,"other":2,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OWB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2026 Q2: 1,181 adverse event reports received by the FDA (4 death, 10 injury, 1,166 malfunction and 1 other).","value":1181,"unit":"device adverse event reports received","reports":1181,"deaths":4,"injuries":10,"malfunctions":1166,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2026 Q2: 1,135 adverse event reports received by the FDA (0 death, 79 injury, 1,056 malfunction and 0 other).","value":1135,"unit":"device adverse event reports received","reports":1135,"deaths":0,"injuries":79,"malfunctions":1056,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FOZ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2026 Q2: 1,130 adverse event reports received by the FDA (1 death, 96 injury, 1,033 malfunction and 0 other).","value":1130,"unit":"device adverse event reports received","reports":1130,"deaths":1,"injuries":96,"malfunctions":1033,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2026 Q2: 1,121 adverse event reports received by the FDA (0 death, 34 injury, 1,087 malfunction and 0 other).","value":1121,"unit":"device adverse event reports received","reports":1121,"deaths":0,"injuries":34,"malfunctions":1087,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2026 Q2: 1,117 adverse event reports received by the FDA (0 death, 12 injury, 1,105 malfunction and 0 other).","value":1117,"unit":"device adverse event reports received","reports":1117,"deaths":0,"injuries":12,"malfunctions":1105,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2026 Q2: 1,117 adverse event reports received by the FDA (3 death, 5 injury, 1,109 malfunction and 0 other).","value":1117,"unit":"device adverse event reports received","reports":1117,"deaths":3,"injuries":5,"malfunctions":1109,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2026 Q2: 1,077 adverse event reports received by the FDA (54 death, 791 injury, 232 malfunction and 0 other).","value":1077,"unit":"device adverse event reports received","reports":1077,"deaths":54,"injuries":791,"malfunctions":232,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2026 Q2: 1,055 adverse event reports received by the FDA (1 death, 488 injury, 566 malfunction and 0 other).","value":1055,"unit":"device adverse event reports received","reports":1055,"deaths":1,"injuries":488,"malfunctions":566,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2026 Q2: 1,036 adverse event reports received by the FDA (0 death, 52 injury, 984 malfunction and 0 other).","value":1036,"unit":"device adverse event reports received","reports":1036,"deaths":0,"injuries":52,"malfunctions":984,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SBA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2026 Q2: 1,032 adverse event reports received by the FDA (0 death, 183 injury, 849 malfunction and 0 other).","value":1032,"unit":"device adverse event reports received","reports":1032,"deaths":0,"injuries":183,"malfunctions":849,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Syringe, Piston (product code FMF), 2026 Q2: 1,023 adverse event reports received by the FDA (0 death, 86 injury, 937 malfunction and 0 other).","value":1023,"unit":"device adverse event reports received","reports":1023,"deaths":0,"injuries":86,"malfunctions":937,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2026 Q2: 989 adverse event reports received by the FDA (147 death, 530 injury, 312 malfunction and 0 other).","value":989,"unit":"device adverse event reports received","reports":989,"deaths":147,"injuries":530,"malfunctions":312,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2026 Q2: 960 adverse event reports received by the FDA (0 death, 5 injury, 955 malfunction and 0 other).","value":960,"unit":"device adverse event reports received","reports":960,"deaths":0,"injuries":5,"malfunctions":955,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2026 Q2: 918 adverse event reports received by the FDA (0 death, 128 injury, 790 malfunction and 0 other).","value":918,"unit":"device adverse event reports received","reports":918,"deaths":0,"injuries":128,"malfunctions":790,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2026 Q2: 906 adverse event reports received by the FDA (0 death, 0 injury, 906 malfunction and 0 other).","value":906,"unit":"device adverse event reports received","reports":906,"deaths":0,"injuries":0,"malfunctions":906,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2026 Q2: 880 adverse event reports received by the FDA (1 death, 154 injury, 725 malfunction and 0 other).","value":880,"unit":"device adverse event reports received","reports":880,"deaths":1,"injuries":154,"malfunctions":725,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Percutaneous (product code DQY), 2026 Q2: 866 adverse event reports received by the FDA (18 death, 214 injury, 634 malfunction and 0 other).","value":866,"unit":"device adverse event reports received","reports":866,"deaths":18,"injuries":214,"malfunctions":634,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2026 Q2: 865 adverse event reports received by the FDA (1 death, 212 injury, 650 malfunction and 2 other).","value":865,"unit":"device adverse event reports received","reports":865,"deaths":1,"injuries":212,"malfunctions":650,"other":2,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2026 Q2: 843 adverse event reports received by the FDA (14 death, 469 injury, 360 malfunction and 0 other).","value":843,"unit":"device adverse event reports received","reports":843,"deaths":14,"injuries":469,"malfunctions":360,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2026 Q2: 838 adverse event reports received by the FDA (7 death, 371 injury, 460 malfunction and 0 other).","value":838,"unit":"device adverse event reports received","reports":838,"deaths":7,"injuries":371,"malfunctions":460,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MIH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2026 Q2: 834 adverse event reports received by the FDA (38 death, 617 injury, 179 malfunction and 0 other).","value":834,"unit":"device adverse event reports received","reports":834,"deaths":38,"injuries":617,"malfunctions":179,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Plate, Bone (product code JEY), 2026 Q2: 831 adverse event reports received by the FDA (0 death, 58 injury, 773 malfunction and 0 other).","value":831,"unit":"device adverse event reports received","reports":831,"deaths":0,"injuries":58,"malfunctions":773,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2026 Q2: 818 adverse event reports received by the FDA (4 death, 319 injury, 495 malfunction and 0 other).","value":818,"unit":"device adverse event reports received","reports":818,"deaths":4,"injuries":319,"malfunctions":495,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2026 Q2: 804 adverse event reports received by the FDA (27 death, 694 injury, 83 malfunction and 0 other).","value":804,"unit":"device adverse event reports received","reports":804,"deaths":27,"injuries":694,"malfunctions":83,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2026 Q2: 795 adverse event reports received by the FDA (0 death, 31 injury, 764 malfunction and 0 other).","value":795,"unit":"device adverse event reports received","reports":795,"deaths":0,"injuries":31,"malfunctions":764,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Instrument, Biopsy (product code KNW), 2026 Q2: 791 adverse event reports received by the FDA (0 death, 68 injury, 723 malfunction and 0 other).","value":791,"unit":"device adverse event reports received","reports":791,"deaths":0,"injuries":68,"malfunctions":723,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LLI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LLI","deviceName":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (product code LLI), 2026 Q2: 787 adverse event reports received by the FDA (1 death, 4 injury, 782 malfunction and 0 other).","value":787,"unit":"device adverse event reports received","reports":787,"deaths":1,"injuries":4,"malfunctions":782,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2026 Q2: 786 adverse event reports received by the FDA (2 death, 5 injury, 779 malfunction and 0 other).","value":786,"unit":"device adverse event reports received","reports":786,"deaths":2,"injuries":5,"malfunctions":779,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2026 Q2: 773 adverse event reports received by the FDA (5 death, 16 injury, 752 malfunction and 0 other).","value":773,"unit":"device adverse event reports received","reports":773,"deaths":5,"injuries":16,"malfunctions":752,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PHX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2026 Q2: 772 adverse event reports received by the FDA (0 death, 701 injury, 71 malfunction and 0 other).","value":772,"unit":"device adverse event reports received","reports":772,"deaths":0,"injuries":701,"malfunctions":71,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2026 Q2: 766 adverse event reports received by the FDA (3 death, 104 injury, 659 malfunction and 0 other).","value":766,"unit":"device adverse event reports received","reports":766,"deaths":3,"injuries":104,"malfunctions":659,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2026 Q2: 749 adverse event reports received by the FDA (4 death, 1 injury, 744 malfunction and 0 other).","value":749,"unit":"device adverse event reports received","reports":749,"deaths":4,"injuries":1,"malfunctions":744,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2026 Q2: 749 adverse event reports received by the FDA (2 death, 3 injury, 744 malfunction and 0 other).","value":749,"unit":"device adverse event reports received","reports":749,"deaths":2,"injuries":3,"malfunctions":744,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FKX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2026 Q2: 746 adverse event reports received by the FDA (23 death, 331 injury, 392 malfunction and 0 other).","value":746,"unit":"device adverse event reports received","reports":746,"deaths":23,"injuries":331,"malfunctions":392,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2026 Q2: 746 adverse event reports received by the FDA (0 death, 702 injury, 44 malfunction and 0 other).","value":746,"unit":"device adverse event reports received","reports":746,"deaths":0,"injuries":702,"malfunctions":44,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SCV:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SCV","deviceName":"Modular Electromechanical Surgical System","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Modular Electromechanical Surgical System (product code SCV), 2026 Q2: 743 adverse event reports received by the FDA (0 death, 20 injury, 723 malfunction and 0 other).","value":743,"unit":"device adverse event reports received","reports":743,"deaths":0,"injuries":20,"malfunctions":723,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FHW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2026 Q2: 733 adverse event reports received by the FDA (0 death, 689 injury, 44 malfunction and 0 other).","value":733,"unit":"device adverse event reports received","reports":733,"deaths":0,"injuries":689,"malfunctions":44,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2026 Q2: 731 adverse event reports received by the FDA (3 death, 90 injury, 638 malfunction and 0 other).","value":731,"unit":"device adverse event reports received","reports":731,"deaths":3,"injuries":90,"malfunctions":638,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OLO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2026 Q2: 714 adverse event reports received by the FDA (0 death, 67 injury, 647 malfunction and 0 other).","value":714,"unit":"device adverse event reports received","reports":714,"deaths":0,"injuries":67,"malfunctions":647,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIQ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2026 Q2: 687 adverse event reports received by the FDA (33 death, 233 injury, 421 malfunction and 0 other).","value":687,"unit":"device adverse event reports received","reports":687,"deaths":33,"injuries":233,"malfunctions":421,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Template (product code HWT), 2026 Q2: 685 adverse event reports received by the FDA (0 death, 4 injury, 681 malfunction and 0 other).","value":685,"unit":"device adverse event reports received","reports":685,"deaths":0,"injuries":4,"malfunctions":681,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2026 Q2: 674 adverse event reports received by the FDA (0 death, 19 injury, 655 malfunction and 0 other).","value":674,"unit":"device adverse event reports received","reports":674,"deaths":0,"injuries":19,"malfunctions":655,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2026 Q2: 668 adverse event reports received by the FDA (1 death, 589 injury, 78 malfunction and 0 other).","value":668,"unit":"device adverse event reports received","reports":668,"deaths":1,"injuries":589,"malfunctions":78,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NEW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2026 Q2: 664 adverse event reports received by the FDA (0 death, 101 injury, 563 malfunction and 0 other).","value":664,"unit":"device adverse event reports received","reports":664,"deaths":0,"injuries":101,"malfunctions":563,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Steerable (product code DRA), 2026 Q2: 636 adverse event reports received by the FDA (8 death, 169 injury, 459 malfunction and 0 other).","value":636,"unit":"device adverse event reports received","reports":636,"deaths":8,"injuries":169,"malfunctions":459,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2026 Q2: 613 adverse event reports received by the FDA (3 death, 198 injury, 412 malfunction and 0 other).","value":613,"unit":"device adverse event reports received","reports":613,"deaths":3,"injuries":198,"malfunctions":412,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2026 Q2: 611 adverse event reports received by the FDA (33 death, 533 injury, 45 malfunction and 0 other).","value":611,"unit":"device adverse event reports received","reports":611,"deaths":33,"injuries":533,"malfunctions":45,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2026 Q2: 606 adverse event reports received by the FDA (0 death, 14 injury, 592 malfunction and 0 other).","value":606,"unit":"device adverse event reports received","reports":606,"deaths":0,"injuries":14,"malfunctions":592,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2026 Q2: 605 adverse event reports received by the FDA (16 death, 51 injury, 538 malfunction and 0 other).","value":605,"unit":"device adverse event reports received","reports":605,"deaths":16,"injuries":51,"malfunctions":538,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NHA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2026 Q2: 603 adverse event reports received by the FDA (0 death, 402 injury, 201 malfunction and 0 other).","value":603,"unit":"device adverse event reports received","reports":603,"deaths":0,"injuries":402,"malfunctions":201,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MOM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2026 Q2: 595 adverse event reports received by the FDA (1 death, 179 injury, 415 malfunction and 0 other).","value":595,"unit":"device adverse event reports received","reports":595,"deaths":1,"injuries":179,"malfunctions":415,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2026 Q2: 587 adverse event reports received by the FDA (0 death, 30 injury, 557 malfunction and 0 other).","value":587,"unit":"device adverse event reports received","reports":587,"deaths":0,"injuries":30,"malfunctions":557,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NGV:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2026 Q2: 574 adverse event reports received by the FDA (66 death, 473 injury, 35 malfunction and 0 other).","value":574,"unit":"device adverse event reports received","reports":574,"deaths":66,"injuries":473,"malfunctions":35,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2026 Q2: 565 adverse event reports received by the FDA (0 death, 288 injury, 277 malfunction and 0 other).","value":565,"unit":"device adverse event reports received","reports":565,"deaths":0,"injuries":288,"malfunctions":277,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Impactor (product code HWA), 2026 Q2: 542 adverse event reports received by the FDA (0 death, 2 injury, 540 malfunction and 0 other).","value":542,"unit":"device adverse event reports received","reports":542,"deaths":0,"injuries":2,"malfunctions":540,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2026 Q2: 533 adverse event reports received by the FDA (0 death, 2 injury, 531 malfunction and 0 other).","value":533,"unit":"device adverse event reports received","reports":533,"deaths":0,"injuries":2,"malfunctions":531,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LIT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2026 Q2: 529 adverse event reports received by the FDA (2 death, 43 injury, 484 malfunction and 0 other).","value":529,"unit":"device adverse event reports received","reports":529,"deaths":2,"injuries":43,"malfunctions":484,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2026 Q2: 526 adverse event reports received by the FDA (0 death, 128 injury, 398 malfunction and 0 other).","value":526,"unit":"device adverse event reports received","reports":526,"deaths":0,"injuries":128,"malfunctions":398,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PMP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2026 Q2: 519 adverse event reports received by the FDA (1 death, 510 injury, 8 malfunction and 0 other).","value":519,"unit":"device adverse event reports received","reports":519,"deaths":1,"injuries":510,"malfunctions":8,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2026 Q2: 511 adverse event reports received by the FDA (20 death, 217 injury, 273 malfunction and 1 other).","value":511,"unit":"device adverse event reports received","reports":511,"deaths":20,"injuries":217,"malfunctions":273,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2026 Q2: 507 adverse event reports received by the FDA (0 death, 206 injury, 301 malfunction and 0 other).","value":507,"unit":"device adverse event reports received","reports":507,"deaths":0,"injuries":206,"malfunctions":301,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Arthroscope (product code HRX), 2026 Q2: 504 adverse event reports received by the FDA (0 death, 22 injury, 482 malfunction and 0 other).","value":504,"unit":"device adverse event reports received","reports":504,"deaths":0,"injuries":22,"malfunctions":482,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2026 Q2: 503 adverse event reports received by the FDA (1 death, 371 injury, 131 malfunction and 0 other).","value":503,"unit":"device adverse event reports received","reports":503,"deaths":1,"injuries":371,"malfunctions":131,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FJK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2026 Q2: 495 adverse event reports received by the FDA (0 death, 17 injury, 475 malfunction and 3 other).","value":495,"unit":"device adverse event reports received","reports":495,"deaths":0,"injuries":17,"malfunctions":475,"other":3,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NZU:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2026 Q2: 494 adverse event reports received by the FDA (1 death, 126 injury, 367 malfunction and 0 other).","value":494,"unit":"device adverse event reports received","reports":494,"deaths":1,"injuries":126,"malfunctions":367,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2026 Q2: 488 adverse event reports received by the FDA (5 death, 70 injury, 413 malfunction and 0 other).","value":488,"unit":"device adverse event reports received","reports":488,"deaths":5,"injuries":70,"malfunctions":413,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LMH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2026 Q2: 485 adverse event reports received by the FDA (2 death, 480 injury, 3 malfunction and 0 other).","value":485,"unit":"device adverse event reports received","reports":485,"deaths":2,"injuries":480,"malfunctions":3,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2026 Q2: 484 adverse event reports received by the FDA (0 death, 48 injury, 436 malfunction and 0 other).","value":484,"unit":"device adverse event reports received","reports":484,"deaths":0,"injuries":48,"malfunctions":436,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OUT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2026 Q2: 468 adverse event reports received by the FDA (4 death, 78 injury, 386 malfunction and 0 other).","value":468,"unit":"device adverse event reports received","reports":468,"deaths":4,"injuries":78,"malfunctions":386,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2026 Q2: 465 adverse event reports received by the FDA (0 death, 463 injury, 2 malfunction and 0 other).","value":465,"unit":"device adverse event reports received","reports":465,"deaths":0,"injuries":463,"malfunctions":2,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Bit, Drill (product code HTW), 2026 Q2: 451 adverse event reports received by the FDA (0 death, 15 injury, 436 malfunction and 0 other).","value":451,"unit":"device adverse event reports received","reports":451,"deaths":0,"injuries":15,"malfunctions":436,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2026 Q2: 447 adverse event reports received by the FDA (4 death, 67 injury, 375 malfunction and 1 other).","value":447,"unit":"device adverse event reports received","reports":447,"deaths":4,"injuries":67,"malfunctions":375,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Clip, Implantable (product code FZP), 2026 Q2: 444 adverse event reports received by the FDA (2 death, 21 injury, 421 malfunction and 0 other).","value":444,"unit":"device adverse event reports received","reports":444,"deaths":2,"injuries":21,"malfunctions":421,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2026 Q2: 444 adverse event reports received by the FDA (0 death, 360 injury, 84 malfunction and 0 other).","value":444,"unit":"device adverse event reports received","reports":444,"deaths":0,"injuries":360,"malfunctions":84,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ERL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2026 Q2: 438 adverse event reports received by the FDA (0 death, 3 injury, 435 malfunction and 0 other).","value":438,"unit":"device adverse event reports received","reports":438,"deaths":0,"injuries":3,"malfunctions":435,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2026 Q2: 438 adverse event reports received by the FDA (5 death, 116 injury, 317 malfunction and 0 other).","value":438,"unit":"device adverse event reports received","reports":438,"deaths":5,"injuries":116,"malfunctions":317,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QCB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2026 Q2: 436 adverse event reports received by the FDA (0 death, 436 injury, 0 malfunction and 0 other).","value":436,"unit":"device adverse event reports received","reports":436,"deaths":0,"injuries":436,"malfunctions":0,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stapler, Surgical (product code GAG), 2026 Q2: 432 adverse event reports received by the FDA (2 death, 36 injury, 394 malfunction and 0 other).","value":432,"unit":"device adverse event reports received","reports":432,"deaths":2,"injuries":36,"malfunctions":394,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2026 Q2: 428 adverse event reports received by the FDA (3 death, 248 injury, 177 malfunction and 0 other).","value":428,"unit":"device adverse event reports received","reports":428,"deaths":3,"injuries":248,"malfunctions":177,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2026 Q2: 425 adverse event reports received by the FDA (0 death, 423 injury, 2 malfunction and 0 other).","value":425,"unit":"device adverse event reports received","reports":425,"deaths":0,"injuries":423,"malfunctions":2,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HXX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Screwdriver (product code HXX), 2026 Q2: 425 adverse event reports received by the FDA (0 death, 14 injury, 411 malfunction and 0 other).","value":425,"unit":"device adverse event reports received","reports":425,"deaths":0,"injuries":14,"malfunctions":411,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JDI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2026 Q2: 422 adverse event reports received by the FDA (2 death, 383 injury, 37 malfunction and 0 other).","value":422,"unit":"device adverse event reports received","reports":422,"deaths":2,"injuries":383,"malfunctions":37,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Replacement Heart-Valve (product code DYE), 2026 Q2: 404 adverse event reports received by the FDA (9 death, 347 injury, 48 malfunction and 0 other).","value":404,"unit":"device adverse event reports received","reports":404,"deaths":9,"injuries":347,"malfunctions":48,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2026 Q2: 402 adverse event reports received by the FDA (0 death, 17 injury, 385 malfunction and 0 other).","value":402,"unit":"device adverse event reports received","reports":402,"deaths":0,"injuries":17,"malfunctions":385,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Walker, Mechanical (product code ITJ), 2026 Q2: 401 adverse event reports received by the FDA (0 death, 36 injury, 365 malfunction and 0 other).","value":401,"unit":"device adverse event reports received","reports":401,"deaths":0,"injuries":36,"malfunctions":365,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2026 Q2: 398 adverse event reports received by the FDA (1 death, 69 injury, 328 malfunction and 0 other).","value":398,"unit":"device adverse event reports received","reports":398,"deaths":1,"injuries":69,"malfunctions":328,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2026 Q2: 386 adverse event reports received by the FDA (0 death, 49 injury, 337 malfunction and 0 other).","value":386,"unit":"device adverse event reports received","reports":386,"deaths":0,"injuries":49,"malfunctions":337,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LHI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2026 Q2: 385 adverse event reports received by the FDA (0 death, 0 injury, 385 malfunction and 0 other).","value":385,"unit":"device adverse event reports received","reports":385,"deaths":0,"injuries":0,"malfunctions":385,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2026 Q2: 385 adverse event reports received by the FDA (0 death, 22 injury, 363 malfunction and 0 other).","value":385,"unit":"device adverse event reports received","reports":385,"deaths":0,"injuries":22,"malfunctions":363,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Thermal Regulating (product code DWJ), 2026 Q2: 382 adverse event reports received by the FDA (0 death, 11 injury, 371 malfunction and 0 other).","value":382,"unit":"device adverse event reports received","reports":382,"deaths":0,"injuries":11,"malfunctions":371,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2026 Q2: 377 adverse event reports received by the FDA (1 death, 8 injury, 368 malfunction and 0 other).","value":377,"unit":"device adverse event reports received","reports":377,"deaths":1,"injuries":8,"malfunctions":368,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Device, Anti-Snoring (product code LRK), 2026 Q2: 374 adverse event reports received by the FDA (0 death, 20 injury, 354 malfunction and 0 other).","value":374,"unit":"device adverse event reports received","reports":374,"deaths":0,"injuries":20,"malfunctions":354,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LYJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2026 Q2: 374 adverse event reports received by the FDA (15 death, 160 injury, 199 malfunction and 0 other).","value":374,"unit":"device adverse event reports received","reports":374,"deaths":15,"injuries":160,"malfunctions":199,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2026 Q2: 370 adverse event reports received by the FDA (2 death, 42 injury, 326 malfunction and 0 other).","value":370,"unit":"device adverse event reports received","reports":370,"deaths":2,"injuries":42,"malfunctions":326,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2026 Q2: 368 adverse event reports received by the FDA (1 death, 62 injury, 305 malfunction and 0 other).","value":368,"unit":"device adverse event reports received","reports":368,"deaths":1,"injuries":62,"malfunctions":305,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2026 Q2: 362 adverse event reports received by the FDA (0 death, 195 injury, 167 malfunction and 0 other).","value":362,"unit":"device adverse event reports received","reports":362,"deaths":0,"injuries":195,"malfunctions":167,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Clamp, Vascular (product code DXC), 2026 Q2: 361 adverse event reports received by the FDA (1 death, 17 injury, 343 malfunction and 0 other).","value":361,"unit":"device adverse event reports received","reports":361,"deaths":1,"injuries":17,"malfunctions":343,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KOD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Urological (product code KOD), 2026 Q2: 360 adverse event reports received by the FDA (1 death, 39 injury, 320 malfunction and 0 other).","value":360,"unit":"device adverse event reports received","reports":360,"deaths":1,"injuries":39,"malfunctions":320,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SAF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2026 Q2: 360 adverse event reports received by the FDA (0 death, 42 injury, 318 malfunction and 0 other).","value":360,"unit":"device adverse event reports received","reports":360,"deaths":0,"injuries":42,"malfunctions":318,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MFK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2026 Q2: 357 adverse event reports received by the FDA (0 death, 227 injury, 130 malfunction and 0 other).","value":357,"unit":"device adverse event reports received","reports":357,"deaths":0,"injuries":227,"malfunctions":130,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2026 Q2: 354 adverse event reports received by the FDA (0 death, 1 injury, 353 malfunction and 0 other).","value":354,"unit":"device adverse event reports received","reports":354,"deaths":0,"injuries":1,"malfunctions":353,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2026 Q2: 352 adverse event reports received by the FDA (0 death, 48 injury, 304 malfunction and 0 other).","value":352,"unit":"device adverse event reports received","reports":352,"deaths":0,"injuries":48,"malfunctions":304,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JCW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2026 Q2: 346 adverse event reports received by the FDA (0 death, 331 injury, 15 malfunction and 0 other).","value":346,"unit":"device adverse event reports received","reports":346,"deaths":0,"injuries":331,"malfunctions":15,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2026 Q2: 336 adverse event reports received by the FDA (0 death, 44 injury, 292 malfunction and 0 other).","value":336,"unit":"device adverse event reports received","reports":336,"deaths":0,"injuries":44,"malfunctions":292,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2026 Q2: 333 adverse event reports received by the FDA (0 death, 7 injury, 326 malfunction and 0 other).","value":333,"unit":"device adverse event reports received","reports":333,"deaths":0,"injuries":7,"malfunctions":326,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LOX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2026 Q2: 320 adverse event reports received by the FDA (2 death, 41 injury, 277 malfunction and 0 other).","value":320,"unit":"device adverse event reports received","reports":320,"deaths":2,"injuries":41,"malfunctions":277,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Driver, Prosthesis (product code HWR), 2026 Q2: 317 adverse event reports received by the FDA (0 death, 5 injury, 312 malfunction and 0 other).","value":317,"unit":"device adverse event reports received","reports":317,"deaths":0,"injuries":5,"malfunctions":312,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2026 Q2: 315 adverse event reports received by the FDA (1 death, 217 injury, 97 malfunction and 0 other).","value":315,"unit":"device adverse event reports received","reports":315,"deaths":1,"injuries":217,"malfunctions":97,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JXG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2026 Q2: 312 adverse event reports received by the FDA (6 death, 184 injury, 122 malfunction and 0 other).","value":312,"unit":"device adverse event reports received","reports":312,"deaths":6,"injuries":184,"malfunctions":122,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IZI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2026 Q2: 310 adverse event reports received by the FDA (0 death, 0 injury, 310 malfunction and 0 other).","value":310,"unit":"device adverse event reports received","reports":310,"deaths":0,"injuries":0,"malfunctions":310,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTZ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2026 Q2: 306 adverse event reports received by the FDA (4 death, 32 injury, 270 malfunction and 0 other).","value":306,"unit":"device adverse event reports received","reports":306,"deaths":4,"injuries":32,"malfunctions":270,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2026 Q2: 299 adverse event reports received by the FDA (0 death, 5 injury, 294 malfunction and 0 other).","value":299,"unit":"device adverse event reports received","reports":299,"deaths":0,"injuries":5,"malfunctions":294,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTQ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2026 Q2: 295 adverse event reports received by the FDA (5 death, 3 injury, 287 malfunction and 0 other).","value":295,"unit":"device adverse event reports received","reports":295,"deaths":5,"injuries":3,"malfunctions":287,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OBJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2026 Q2: 292 adverse event reports received by the FDA (4 death, 40 injury, 248 malfunction and 0 other).","value":292,"unit":"device adverse event reports received","reports":292,"deaths":4,"injuries":40,"malfunctions":248,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2026 Q2: 289 adverse event reports received by the FDA (8 death, 18 injury, 263 malfunction and 0 other).","value":289,"unit":"device adverse event reports received","reports":289,"deaths":8,"injuries":18,"malfunctions":263,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Reamer (product code HTO), 2026 Q2: 288 adverse event reports received by the FDA (0 death, 3 injury, 285 malfunction and 0 other).","value":288,"unit":"device adverse event reports received","reports":288,"deaths":0,"injuries":3,"malfunctions":285,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2026 Q2: 284 adverse event reports received by the FDA (0 death, 6 injury, 278 malfunction and 0 other).","value":284,"unit":"device adverse event reports received","reports":284,"deaths":0,"injuries":6,"malfunctions":278,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GBX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Irrigation (product code GBX), 2026 Q2: 282 adverse event reports received by the FDA (0 death, 23 injury, 259 malfunction and 0 other).","value":282,"unit":"device adverse event reports received","reports":282,"deaths":0,"injuries":23,"malfunctions":259,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2026 Q2: 280 adverse event reports received by the FDA (0 death, 4 injury, 276 malfunction and 0 other).","value":280,"unit":"device adverse event reports received","reports":280,"deaths":0,"injuries":4,"malfunctions":276,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JOH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2026 Q2: 274 adverse event reports received by the FDA (2 death, 26 injury, 246 malfunction and 0 other).","value":274,"unit":"device adverse event reports received","reports":274,"deaths":2,"injuries":26,"malfunctions":246,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2026 Q2: 268 adverse event reports received by the FDA (16 death, 94 injury, 158 malfunction and 0 other).","value":268,"unit":"device adverse event reports received","reports":268,"deaths":16,"injuries":94,"malfunctions":158,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2026 Q2: 267 adverse event reports received by the FDA (0 death, 11 injury, 256 malfunction and 0 other).","value":267,"unit":"device adverse event reports received","reports":267,"deaths":0,"injuries":11,"malfunctions":256,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2026 Q2: 267 adverse event reports received by the FDA (4 death, 17 injury, 246 malfunction and 0 other).","value":267,"unit":"device adverse event reports received","reports":267,"deaths":4,"injuries":17,"malfunctions":246,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2026 Q2: 266 adverse event reports received by the FDA (6 death, 30 injury, 230 malfunction and 0 other).","value":266,"unit":"device adverse event reports received","reports":266,"deaths":6,"injuries":30,"malfunctions":230,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Programmer, Pacemaker (product code KRG), 2026 Q2: 266 adverse event reports received by the FDA (0 death, 1 injury, 265 malfunction and 0 other).","value":266,"unit":"device adverse event reports received","reports":266,"deaths":0,"injuries":1,"malfunctions":265,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2026 Q2: 266 adverse event reports received by the FDA (6 death, 121 injury, 139 malfunction and 0 other).","value":266,"unit":"device adverse event reports received","reports":266,"deaths":6,"injuries":121,"malfunctions":139,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2026 Q2: 263 adverse event reports received by the FDA (2 death, 12 injury, 249 malfunction and 0 other).","value":263,"unit":"device adverse event reports received","reports":263,"deaths":2,"injuries":12,"malfunctions":249,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2026 Q2: 260 adverse event reports received by the FDA (27 death, 124 injury, 109 malfunction and 0 other).","value":260,"unit":"device adverse event reports received","reports":260,"deaths":27,"injuries":124,"malfunctions":109,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2026 Q2: 260 adverse event reports received by the FDA (13 death, 161 injury, 86 malfunction and 0 other).","value":260,"unit":"device adverse event reports received","reports":260,"deaths":13,"injuries":161,"malfunctions":86,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2026 Q2: 259 adverse event reports received by the FDA (36 death, 96 injury, 127 malfunction and 0 other).","value":259,"unit":"device adverse event reports received","reports":259,"deaths":36,"injuries":96,"malfunctions":127,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2026 Q2: 255 adverse event reports received by the FDA (4 death, 18 injury, 233 malfunction and 0 other).","value":255,"unit":"device adverse event reports received","reports":255,"deaths":4,"injuries":18,"malfunctions":233,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2026 Q2: 253 adverse event reports received by the FDA (0 death, 19 injury, 233 malfunction and 1 other).","value":253,"unit":"device adverse event reports received","reports":253,"deaths":0,"injuries":19,"malfunctions":233,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GWF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2026 Q2: 252 adverse event reports received by the FDA (0 death, 0 injury, 252 malfunction and 0 other).","value":252,"unit":"device adverse event reports received","reports":252,"deaths":0,"injuries":0,"malfunctions":252,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNQ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2026 Q2: 248 adverse event reports received by the FDA (0 death, 242 injury, 6 malfunction and 0 other).","value":248,"unit":"device adverse event reports received","reports":248,"deaths":0,"injuries":242,"malfunctions":6,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Calculator, Drug Dose (product code NDC), 2026 Q2: 247 adverse event reports received by the FDA (1 death, 68 injury, 178 malfunction and 0 other).","value":247,"unit":"device adverse event reports received","reports":247,"deaths":1,"injuries":68,"malfunctions":178,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Oximeter (product code DQA), 2026 Q2: 245 adverse event reports received by the FDA (0 death, 2 injury, 242 malfunction and 1 other).","value":245,"unit":"device adverse event reports received","reports":245,"deaths":0,"injuries":2,"malfunctions":242,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2026 Q2: 242 adverse event reports received by the FDA (5 death, 22 injury, 215 malfunction and 0 other).","value":242,"unit":"device adverse event reports received","reports":242,"deaths":5,"injuries":22,"malfunctions":215,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PFO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2026 Q2: 240 adverse event reports received by the FDA (0 death, 219 injury, 21 malfunction and 0 other).","value":240,"unit":"device adverse event reports received","reports":240,"deaths":0,"injuries":219,"malfunctions":21,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MLV:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2026 Q2: 237 adverse event reports received by the FDA (9 death, 97 injury, 131 malfunction and 0 other).","value":237,"unit":"device adverse event reports received","reports":237,"deaths":9,"injuries":97,"malfunctions":131,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MMI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2026 Q2: 237 adverse event reports received by the FDA (0 death, 2 injury, 235 malfunction and 0 other).","value":237,"unit":"device adverse event reports received","reports":237,"deaths":0,"injuries":2,"malfunctions":235,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2026 Q2: 234 adverse event reports received by the FDA (1 death, 22 injury, 211 malfunction and 0 other).","value":234,"unit":"device adverse event reports received","reports":234,"deaths":1,"injuries":22,"malfunctions":211,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OAE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2026 Q2: 234 adverse event reports received by the FDA (7 death, 111 injury, 116 malfunction and 0 other).","value":234,"unit":"device adverse event reports received","reports":234,"deaths":7,"injuries":111,"malfunctions":116,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2026 Q2: 233 adverse event reports received by the FDA (2 death, 3 injury, 228 malfunction and 0 other).","value":233,"unit":"device adverse event reports received","reports":233,"deaths":2,"injuries":3,"malfunctions":228,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2026 Q2: 229 adverse event reports received by the FDA (0 death, 215 injury, 14 malfunction and 0 other).","value":229,"unit":"device adverse event reports received","reports":229,"deaths":0,"injuries":215,"malfunctions":14,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2026 Q2: 226 adverse event reports received by the FDA (0 death, 166 injury, 60 malfunction and 0 other).","value":226,"unit":"device adverse event reports received","reports":226,"deaths":0,"injuries":166,"malfunctions":60,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MTA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2026 Q2: 221 adverse event reports received by the FDA (0 death, 210 injury, 11 malfunction and 0 other).","value":221,"unit":"device adverse event reports received","reports":221,"deaths":0,"injuries":210,"malfunctions":11,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2026 Q2: 220 adverse event reports received by the FDA (0 death, 0 injury, 220 malfunction and 0 other).","value":220,"unit":"device adverse event reports received","reports":220,"deaths":0,"injuries":0,"malfunctions":220,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stretcher, Wheeled (product code FPO), 2026 Q2: 213 adverse event reports received by the FDA (2 death, 7 injury, 204 malfunction and 0 other).","value":213,"unit":"device adverse event reports received","reports":213,"deaths":2,"injuries":7,"malfunctions":204,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MND:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ligator, Esophageal (product code MND), 2026 Q2: 212 adverse event reports received by the FDA (0 death, 17 injury, 195 malfunction and 0 other).","value":212,"unit":"device adverse event reports received","reports":212,"deaths":0,"injuries":17,"malfunctions":195,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Coude (product code EZC), 2026 Q2: 210 adverse event reports received by the FDA (0 death, 33 injury, 177 malfunction and 0 other).","value":210,"unit":"device adverse event reports received","reports":210,"deaths":0,"injuries":33,"malfunctions":177,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2026 Q2: 209 adverse event reports received by the FDA (7 death, 15 injury, 187 malfunction and 0 other).","value":209,"unit":"device adverse event reports received","reports":209,"deaths":7,"injuries":15,"malfunctions":187,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IOR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2026 Q2: 207 adverse event reports received by the FDA (1 death, 3 injury, 203 malfunction and 0 other).","value":207,"unit":"device adverse event reports received","reports":207,"deaths":1,"injuries":3,"malfunctions":203,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NOU:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2026 Q2: 205 adverse event reports received by the FDA (4 death, 8 injury, 193 malfunction and 0 other).","value":205,"unit":"device adverse event reports received","reports":205,"deaths":4,"injuries":8,"malfunctions":193,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2026 Q2: 199 adverse event reports received by the FDA (0 death, 5 injury, 194 malfunction and 0 other).","value":199,"unit":"device adverse event reports received","reports":199,"deaths":0,"injuries":5,"malfunctions":194,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2026 Q2: 191 adverse event reports received by the FDA (0 death, 4 injury, 186 malfunction and 1 other).","value":191,"unit":"device adverse event reports received","reports":191,"deaths":0,"injuries":4,"malfunctions":186,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Septostomy (product code DXF), 2026 Q2: 190 adverse event reports received by the FDA (16 death, 114 injury, 60 malfunction and 0 other).","value":190,"unit":"device adverse event reports received","reports":190,"deaths":16,"injuries":114,"malfunctions":60,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2026 Q2: 190 adverse event reports received by the FDA (0 death, 171 injury, 19 malfunction and 0 other).","value":190,"unit":"device adverse event reports received","reports":190,"deaths":0,"injuries":171,"malfunctions":19,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Compressor, Air, Portable (product code BTI), 2026 Q2: 189 adverse event reports received by the FDA (0 death, 2 injury, 187 malfunction and 0 other).","value":189,"unit":"device adverse event reports received","reports":189,"deaths":0,"injuries":2,"malfunctions":187,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2026 Q2: 189 adverse event reports received by the FDA (0 death, 188 injury, 1 malfunction and 0 other).","value":189,"unit":"device adverse event reports received","reports":189,"deaths":0,"injuries":188,"malfunctions":1,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2026 Q2: 188 adverse event reports received by the FDA (0 death, 0 injury, 188 malfunction and 0 other).","value":188,"unit":"device adverse event reports received","reports":188,"deaths":0,"injuries":0,"malfunctions":188,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PRL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2026 Q2: 188 adverse event reports received by the FDA (1 death, 84 injury, 103 malfunction and 0 other).","value":188,"unit":"device adverse event reports received","reports":188,"deaths":1,"injuries":84,"malfunctions":103,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2026 Q2: 186 adverse event reports received by the FDA (0 death, 3 injury, 183 malfunction and 0 other).","value":186,"unit":"device adverse event reports received","reports":186,"deaths":0,"injuries":3,"malfunctions":183,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OCW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2026 Q2: 184 adverse event reports received by the FDA (0 death, 88 injury, 96 malfunction and 0 other).","value":184,"unit":"device adverse event reports received","reports":184,"deaths":0,"injuries":88,"malfunctions":96,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2026 Q2: 181 adverse event reports received by the FDA (0 death, 37 injury, 144 malfunction and 0 other).","value":181,"unit":"device adverse event reports received","reports":181,"deaths":0,"injuries":37,"malfunctions":144,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MZF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Test, Hiv Detection (product code MZF), 2026 Q2: 180 adverse event reports received by the FDA (0 death, 0 injury, 180 malfunction and 0 other).","value":180,"unit":"device adverse event reports received","reports":180,"deaths":0,"injuries":0,"malfunctions":180,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LON:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2026 Q2: 178 adverse event reports received by the FDA (0 death, 1 injury, 177 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":0,"injuries":1,"malfunctions":177,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GFD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Dermatome (product code GFD), 2026 Q2: 177 adverse event reports received by the FDA (0 death, 10 injury, 167 malfunction and 0 other).","value":177,"unit":"device adverse event reports received","reports":177,"deaths":0,"injuries":10,"malfunctions":167,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAD:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stent, Ureteral (product code FAD), 2026 Q2: 174 adverse event reports received by the FDA (0 death, 49 injury, 125 malfunction and 0 other).","value":174,"unit":"device adverse event reports received","reports":174,"deaths":0,"injuries":49,"malfunctions":125,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Endoscope, Rigid (product code GCM), 2026 Q2: 174 adverse event reports received by the FDA (0 death, 0 injury, 174 malfunction and 0 other).","value":174,"unit":"device adverse event reports received","reports":174,"deaths":0,"injuries":0,"malfunctions":174,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2026 Q2: 173 adverse event reports received by the FDA (4 death, 126 injury, 43 malfunction and 0 other).","value":173,"unit":"device adverse event reports received","reports":173,"deaths":4,"injuries":126,"malfunctions":43,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2026 Q2: 172 adverse event reports received by the FDA (1 death, 64 injury, 107 malfunction and 0 other).","value":172,"unit":"device adverse event reports received","reports":172,"deaths":1,"injuries":64,"malfunctions":107,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFR:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2026 Q2: 170 adverse event reports received by the FDA (0 death, 7 injury, 163 malfunction and 0 other).","value":170,"unit":"device adverse event reports received","reports":170,"deaths":0,"injuries":7,"malfunctions":163,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FCG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Biopsy Needle (product code FCG), 2026 Q2: 168 adverse event reports received by the FDA (1 death, 31 injury, 136 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":1,"injuries":31,"malfunctions":136,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FSA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2026 Q2: 165 adverse event reports received by the FDA (4 death, 24 injury, 137 malfunction and 0 other).","value":165,"unit":"device adverse event reports received","reports":165,"deaths":4,"injuries":24,"malfunctions":137,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2026 Q2: 165 adverse event reports received by the FDA (0 death, 10 injury, 155 malfunction and 0 other).","value":165,"unit":"device adverse event reports received","reports":165,"deaths":0,"injuries":10,"malfunctions":155,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2026 Q2: 164 adverse event reports received by the FDA (1 death, 16 injury, 147 malfunction and 0 other).","value":164,"unit":"device adverse event reports received","reports":164,"deaths":1,"injuries":16,"malfunctions":147,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NXC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Aligner, Sequential (product code NXC), 2026 Q2: 164 adverse event reports received by the FDA (0 death, 156 injury, 8 malfunction and 0 other).","value":164,"unit":"device adverse event reports received","reports":164,"deaths":0,"injuries":156,"malfunctions":8,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QHJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2026 Q2: 162 adverse event reports received by the FDA (0 death, 58 injury, 104 malfunction and 0 other).","value":162,"unit":"device adverse event reports received","reports":162,"deaths":0,"injuries":58,"malfunctions":104,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2026 Q2: 161 adverse event reports received by the FDA (0 death, 11 injury, 150 malfunction and 0 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":0,"injuries":11,"malfunctions":150,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ETN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Nerve (product code ETN), 2026 Q2: 161 adverse event reports received by the FDA (0 death, 28 injury, 133 malfunction and 0 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":0,"injuries":28,"malfunctions":133,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2026 Q2: 159 adverse event reports received by the FDA (0 death, 16 injury, 143 malfunction and 0 other).","value":159,"unit":"device adverse event reports received","reports":159,"deaths":0,"injuries":16,"malfunctions":143,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2026 Q2: 156 adverse event reports received by the FDA (0 death, 152 injury, 4 malfunction and 0 other).","value":156,"unit":"device adverse event reports received","reports":156,"deaths":0,"injuries":152,"malfunctions":4,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:POE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2026 Q2: 155 adverse event reports received by the FDA (0 death, 72 injury, 83 malfunction and 0 other).","value":155,"unit":"device adverse event reports received","reports":155,"deaths":0,"injuries":72,"malfunctions":83,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2026 Q2: 154 adverse event reports received by the FDA (0 death, 153 injury, 1 malfunction and 0 other).","value":154,"unit":"device adverse event reports received","reports":154,"deaths":0,"injuries":153,"malfunctions":1,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2026 Q2: 153 adverse event reports received by the FDA (0 death, 21 injury, 132 malfunction and 0 other).","value":153,"unit":"device adverse event reports received","reports":153,"deaths":0,"injuries":21,"malfunctions":132,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2026 Q2: 153 adverse event reports received by the FDA (0 death, 145 injury, 8 malfunction and 0 other).","value":153,"unit":"device adverse event reports received","reports":153,"deaths":0,"injuries":145,"malfunctions":8,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2026 Q2: 153 adverse event reports received by the FDA (0 death, 33 injury, 120 malfunction and 0 other).","value":153,"unit":"device adverse event reports received","reports":153,"deaths":0,"injuries":33,"malfunctions":120,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2026 Q2: 149 adverse event reports received by the FDA (0 death, 4 injury, 145 malfunction and 0 other).","value":149,"unit":"device adverse event reports received","reports":149,"deaths":0,"injuries":4,"malfunctions":145,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2026 Q2: 148 adverse event reports received by the FDA (0 death, 147 injury, 1 malfunction and 0 other).","value":148,"unit":"device adverse event reports received","reports":148,"deaths":0,"injuries":147,"malfunctions":1,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2026 Q2: 146 adverse event reports received by the FDA (0 death, 29 injury, 117 malfunction and 0 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":29,"malfunctions":117,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2026 Q2: 146 adverse event reports received by the FDA (0 death, 0 injury, 146 malfunction and 0 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":0,"malfunctions":146,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GIM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2026 Q2: 140 adverse event reports received by the FDA (0 death, 0 injury, 140 malfunction and 0 other).","value":140,"unit":"device adverse event reports received","reports":140,"deaths":0,"injuries":0,"malfunctions":140,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HCG:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2026 Q2: 140 adverse event reports received by the FDA (0 death, 21 injury, 119 malfunction and 0 other).","value":140,"unit":"device adverse event reports received","reports":140,"deaths":0,"injuries":21,"malfunctions":119,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQK:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2026 Q2: 139 adverse event reports received by the FDA (0 death, 9 injury, 130 malfunction and 0 other).","value":139,"unit":"device adverse event reports received","reports":139,"deaths":0,"injuries":9,"malfunctions":130,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Bariatric Bed (product code OSI), 2026 Q2: 137 adverse event reports received by the FDA (2 death, 2 injury, 133 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":2,"injuries":2,"malfunctions":133,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stent, Iliac (product code NIO), 2026 Q2: 136 adverse event reports received by the FDA (1 death, 47 injury, 88 malfunction and 0 other).","value":136,"unit":"device adverse event reports received","reports":136,"deaths":1,"injuries":47,"malfunctions":88,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2026 Q2: 131 adverse event reports received by the FDA (0 death, 6 injury, 124 malfunction and 1 other).","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":6,"malfunctions":124,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2026 Q2: 130 adverse event reports received by the FDA (0 death, 1 injury, 129 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":1,"malfunctions":129,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NRY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2026 Q2: 128 adverse event reports received by the FDA (5 death, 29 injury, 94 malfunction and 0 other).","value":128,"unit":"device adverse event reports received","reports":128,"deaths":5,"injuries":29,"malfunctions":94,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HNN:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Knife, Ophthalmic (product code HNN), 2026 Q2: 127 adverse event reports received by the FDA (0 death, 8 injury, 119 malfunction and 0 other).","value":127,"unit":"device adverse event reports received","reports":127,"deaths":0,"injuries":8,"malfunctions":119,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NSA:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2026 Q2: 127 adverse event reports received by the FDA (1 death, 2 injury, 124 malfunction and 0 other).","value":127,"unit":"device adverse event reports received","reports":127,"deaths":1,"injuries":2,"malfunctions":124,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FQH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Lavage, Jet (product code FQH), 2026 Q2: 125 adverse event reports received by the FDA (0 death, 1 injury, 124 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":1,"malfunctions":124,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KGX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2026 Q2: 125 adverse event reports received by the FDA (0 death, 82 injury, 43 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":82,"malfunctions":43,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stent, Carotid (product code NIM), 2026 Q2: 125 adverse event reports received by the FDA (9 death, 55 injury, 61 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":9,"injuries":55,"malfunctions":61,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PYX:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2026 Q2: 121 adverse event reports received by the FDA (35 death, 50 injury, 36 malfunction and 0 other).","value":121,"unit":"device adverse event reports received","reports":121,"deaths":35,"injuries":50,"malfunctions":36,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPW:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2026 Q2: 120 adverse event reports received by the FDA (9 death, 101 injury, 10 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":9,"injuries":101,"malfunctions":10,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2026 Q2: 120 adverse event reports received by the FDA (1 death, 11 injury, 108 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":1,"injuries":11,"malfunctions":108,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:INM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"INM","deviceName":"Chair, With Casters","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Chair, With Casters (product code INM), 2026 Q2: 117 adverse event reports received by the FDA (0 death, 4 injury, 113 malfunction and 0 other).","value":117,"unit":"device adverse event reports received","reports":117,"deaths":0,"injuries":4,"malfunctions":113,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONU:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2026 Q2: 113 adverse event reports received by the FDA (0 death, 59 injury, 54 malfunction and 0 other).","value":113,"unit":"device adverse event reports received","reports":113,"deaths":0,"injuries":59,"malfunctions":54,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LNH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2026 Q2: 112 adverse event reports received by the FDA (0 death, 28 injury, 84 malfunction and 0 other).","value":112,"unit":"device adverse event reports received","reports":112,"deaths":0,"injuries":28,"malfunctions":84,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HEB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2026 Q2: 108 adverse event reports received by the FDA (0 death, 6 injury, 102 malfunction and 0 other).","value":108,"unit":"device adverse event reports received","reports":108,"deaths":0,"injuries":6,"malfunctions":102,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2026 Q2: 106 adverse event reports received by the FDA (0 death, 1 injury, 105 malfunction and 0 other).","value":106,"unit":"device adverse event reports received","reports":106,"deaths":0,"injuries":1,"malfunctions":105,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HHS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2026 Q2: 106 adverse event reports received by the FDA (1 death, 105 injury, 0 malfunction and 0 other).","value":106,"unit":"device adverse event reports received","reports":106,"deaths":1,"injuries":105,"malfunctions":0,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LCJ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2026 Q2: 102 adverse event reports received by the FDA (0 death, 83 injury, 19 malfunction and 0 other).","value":102,"unit":"device adverse event reports received","reports":102,"deaths":0,"injuries":83,"malfunctions":19,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MRM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2026 Q2: 102 adverse event reports received by the FDA (1 death, 53 injury, 48 malfunction and 0 other).","value":102,"unit":"device adverse event reports received","reports":102,"deaths":1,"injuries":53,"malfunctions":48,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2026 Q2: 96 adverse event reports received by the FDA (4 death, 32 injury, 60 malfunction and 0 other).","value":96,"unit":"device adverse event reports received","reports":96,"deaths":4,"injuries":32,"malfunctions":60,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2026 Q2: 92 adverse event reports received by the FDA (0 death, 11 injury, 81 malfunction and 0 other).","value":92,"unit":"device adverse event reports received","reports":92,"deaths":0,"injuries":11,"malfunctions":81,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ILS:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Adaptor, Hygiene (product code ILS), 2026 Q2: 90 adverse event reports received by the FDA (0 death, 5 injury, 85 malfunction and 0 other).","value":90,"unit":"device adverse event reports received","reports":90,"deaths":0,"injuries":5,"malfunctions":85,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GZF:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2026 Q2: 89 adverse event reports received by the FDA (2 death, 83 injury, 4 malfunction and 0 other).","value":89,"unit":"device adverse event reports received","reports":89,"deaths":2,"injuries":83,"malfunctions":4,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFL:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2026 Q2: 88 adverse event reports received by the FDA (0 death, 4 injury, 84 malfunction and 0 other).","value":88,"unit":"device adverse event reports received","reports":88,"deaths":0,"injuries":4,"malfunctions":84,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2026 Q2: 87 adverse event reports received by the FDA (0 death, 3 injury, 84 malfunction and 0 other).","value":87,"unit":"device adverse event reports received","reports":87,"deaths":0,"injuries":3,"malfunctions":84,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEQ:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Toothbrush, Powered (product code JEQ), 2026 Q2: 85 adverse event reports received by the FDA (0 death, 4 injury, 81 malfunction and 0 other).","value":85,"unit":"device adverse event reports received","reports":85,"deaths":0,"injuries":4,"malfunctions":81,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOE:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2026 Q2: 83 adverse event reports received by the FDA (0 death, 48 injury, 35 malfunction and 0 other).","value":83,"unit":"device adverse event reports received","reports":83,"deaths":0,"injuries":48,"malfunctions":35,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KTT:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2026 Q2: 79 adverse event reports received by the FDA (2 death, 33 injury, 44 malfunction and 0 other).","value":79,"unit":"device adverse event reports received","reports":79,"deaths":2,"injuries":33,"malfunctions":44,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKU:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2026 Q2: 79 adverse event reports received by the FDA (0 death, 0 injury, 79 malfunction and 0 other).","value":79,"unit":"device adverse event reports received","reports":79,"deaths":0,"injuries":0,"malfunctions":79,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDB:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"System, Blood Culturing (product code MDB), 2026 Q2: 77 adverse event reports received by the FDA (0 death, 1 injury, 76 malfunction and 0 other).","value":77,"unit":"device adverse event reports received","reports":77,"deaths":0,"injuries":1,"malfunctions":76,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNM:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2026 Q2: 63 adverse event reports received by the FDA (0 death, 5 injury, 58 malfunction and 0 other).","value":63,"unit":"device adverse event reports received","reports":63,"deaths":0,"injuries":5,"malfunctions":58,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITI:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Wheelchair, Powered (product code ITI), 2026 Q2: 63 adverse event reports received by the FDA (3 death, 44 injury, 15 malfunction and 1 other).","value":63,"unit":"device adverse event reports received","reports":63,"deaths":3,"injuries":44,"malfunctions":15,"other":1,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Urethroscope (product code FGC), 2026 Q2: 59 adverse event reports received by the FDA (0 death, 0 injury, 59 malfunction and 0 other).","value":59,"unit":"device adverse event reports received","reports":59,"deaths":0,"injuries":0,"malfunctions":59,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJH:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Orthopedic Tray (product code OJH), 2026 Q2: 55 adverse event reports received by the FDA (0 death, 6 injury, 49 malfunction and 0 other).","value":55,"unit":"device adverse event reports received","reports":55,"deaths":0,"injuries":6,"malfunctions":49,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTC:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTC","deviceName":"Analyzer, Pacemaker Generator Function","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Analyzer, Pacemaker Generator Function (product code DTC), 2026 Q2: 31 adverse event reports received by the FDA (0 death, 0 injury, 31 malfunction and 0 other).","value":31,"unit":"device adverse event reports received","reports":31,"deaths":0,"injuries":0,"malfunctions":31,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KMY:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2026 Q2: 31 adverse event reports received by the FDA (0 death, 28 injury, 3 malfunction and 0 other).","value":31,"unit":"device adverse event reports received","reports":31,"deaths":0,"injuries":28,"malfunctions":3,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QKP:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2026 Q2: 22 adverse event reports received by the FDA (0 death, 1 injury, 21 malfunction and 0 other).","value":22,"unit":"device adverse event reports received","reports":22,"deaths":0,"injuries":1,"malfunctions":21,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NQO:2026Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NQO","deviceName":"Prosthesis, Spinous Process Spacer/Plate","specialty":"Unknown","deviceClass":"3","quarter":"2026Q2","year":2026,"qtr":2,"periodStart":"2026-04-01","periodEnd":"2026-06-30","status":"P","text":"Prosthesis, Spinous Process Spacer/Plate (product code NQO), 2026 Q2: 10 adverse event reports received by the FDA (0 death, 6 injury, 4 malfunction and 0 other).","value":10,"unit":"device adverse event reports received","reports":10,"deaths":0,"injuries":6,"malfunctions":4,"other":0,"effectiveFrom":"2026-04-01","effectiveTo":"2026-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DZE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2026 Q1: 188,176 adverse event reports received by the FDA (0 death, 187,649 injury, 527 malfunction and 0 other).","value":188176,"unit":"device adverse event reports received","reports":188176,"deaths":0,"injuries":187649,"malfunctions":527,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2026 Q1: 135,951 adverse event reports received by the FDA (52 death, 4,008 injury, 131,884 malfunction and 7 other).","value":135951,"unit":"device adverse event reports received","reports":135951,"deaths":52,"injuries":4008,"malfunctions":131884,"other":7,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QFG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2026 Q1: 97,203 adverse event reports received by the FDA (32 death, 11,603 injury, 85,568 malfunction and 0 other).","value":97203,"unit":"device adverse event reports received","reports":97203,"deaths":32,"injuries":11603,"malfunctions":85568,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2026 Q1: 36,901 adverse event reports received by the FDA (21 death, 5,669 injury, 31,211 malfunction and 0 other).","value":36901,"unit":"device adverse event reports received","reports":36901,"deaths":21,"injuries":5669,"malfunctions":31211,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2026 Q1: 19,827 adverse event reports received by the FDA (25 death, 476 injury, 19,326 malfunction and 0 other).","value":19827,"unit":"device adverse event reports received","reports":19827,"deaths":25,"injuries":476,"malfunctions":19326,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BZD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2026 Q1: 16,867 adverse event reports received by the FDA (45 death, 53 injury, 16,769 malfunction and 0 other).","value":16867,"unit":"device adverse event reports received","reports":16867,"deaths":45,"injuries":53,"malfunctions":16769,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2026 Q1: 14,346 adverse event reports received by the FDA (0 death, 16 injury, 14,330 malfunction and 0 other).","value":14346,"unit":"device adverse event reports received","reports":14346,"deaths":0,"injuries":16,"malfunctions":14330,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2026 Q1: 13,935 adverse event reports received by the FDA (9 death, 3,132 injury, 10,791 malfunction and 3 other).","value":13935,"unit":"device adverse event reports received","reports":13935,"deaths":9,"injuries":3132,"malfunctions":10791,"other":3,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FRN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pump, Infusion (product code FRN), 2026 Q1: 12,380 adverse event reports received by the FDA (22 death, 160 injury, 12,196 malfunction and 2 other).","value":12380,"unit":"device adverse event reports received","reports":12380,"deaths":22,"injuries":160,"malfunctions":12196,"other":2,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BRY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2026 Q1: 11,933 adverse event reports received by the FDA (0 death, 4 injury, 11,929 malfunction and 0 other).","value":11933,"unit":"device adverse event reports received","reports":11933,"deaths":0,"injuries":4,"malfunctions":11929,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2026 Q1: 10,568 adverse event reports received by the FDA (0 death, 22 injury, 10,546 malfunction and 0 other).","value":10568,"unit":"device adverse event reports received","reports":10568,"deaths":0,"injuries":22,"malfunctions":10546,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2026 Q1: 9,752 adverse event reports received by the FDA (0 death, 9 injury, 9,743 malfunction and 0 other).","value":9752,"unit":"device adverse event reports received","reports":9752,"deaths":0,"injuries":9,"malfunctions":9743,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2026 Q1: 8,193 adverse event reports received by the FDA (0 death, 8,071 injury, 117 malfunction and 5 other).","value":8193,"unit":"device adverse event reports received","reports":8193,"deaths":0,"injuries":8071,"malfunctions":117,"other":5,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PQF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2026 Q1: 8,066 adverse event reports received by the FDA (0 death, 35 injury, 8,031 malfunction and 0 other).","value":8066,"unit":"device adverse event reports received","reports":8066,"deaths":0,"injuries":35,"malfunctions":8031,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LGW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2026 Q1: 7,114 adverse event reports received by the FDA (8 death, 5,603 injury, 1,503 malfunction and 0 other).","value":7114,"unit":"device adverse event reports received","reports":7114,"deaths":8,"injuries":5603,"malfunctions":1503,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2026 Q1: 6,295 adverse event reports received by the FDA (44 death, 2,451 injury, 3,800 malfunction and 0 other).","value":6295,"unit":"device adverse event reports received","reports":6295,"deaths":44,"injuries":2451,"malfunctions":3800,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2026 Q1: 5,886 adverse event reports received by the FDA (60 death, 3,352 injury, 2,474 malfunction and 0 other).","value":5886,"unit":"device adverse event reports received","reports":5886,"deaths":60,"injuries":3352,"malfunctions":2474,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2026 Q1: 5,765 adverse event reports received by the FDA (46 death, 3,297 injury, 2,421 malfunction and 1 other).","value":5765,"unit":"device adverse event reports received","reports":5765,"deaths":46,"injuries":3297,"malfunctions":2421,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2026 Q1: 5,432 adverse event reports received by the FDA (1,080 death, 3,107 injury, 1,245 malfunction and 0 other).","value":5432,"unit":"device adverse event reports received","reports":5432,"deaths":1080,"injuries":3107,"malfunctions":1245,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2026 Q1: 4,951 adverse event reports received by the FDA (12 death, 2,642 injury, 2,297 malfunction and 0 other).","value":4951,"unit":"device adverse event reports received","reports":4951,"deaths":12,"injuries":2642,"malfunctions":2297,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FET:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2026 Q1: 4,062 adverse event reports received by the FDA (0 death, 24 injury, 4,038 malfunction and 0 other).","value":4062,"unit":"device adverse event reports received","reports":4062,"deaths":0,"injuries":24,"malfunctions":4038,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QLG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2026 Q1: 3,607 adverse event reports received by the FDA (2 death, 392 injury, 3,213 malfunction and 0 other).","value":3607,"unit":"device adverse event reports received","reports":3607,"deaths":2,"injuries":392,"malfunctions":3213,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CBK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2026 Q1: 3,306 adverse event reports received by the FDA (17 death, 48 injury, 3,241 malfunction and 0 other).","value":3306,"unit":"device adverse event reports received","reports":3306,"deaths":17,"injuries":48,"malfunctions":3241,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2026 Q1: 3,301 adverse event reports received by the FDA (329 death, 2,300 injury, 672 malfunction and 0 other).","value":3301,"unit":"device adverse event reports received","reports":3301,"deaths":329,"injuries":2300,"malfunctions":672,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2026 Q1: 3,067 adverse event reports received by the FDA (17 death, 21 injury, 3,029 malfunction and 0 other).","value":3067,"unit":"device adverse event reports received","reports":3067,"deaths":17,"injuries":21,"malfunctions":3029,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MVK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2026 Q1: 3,053 adverse event reports received by the FDA (61 death, 922 injury, 2,070 malfunction and 0 other).","value":3053,"unit":"device adverse event reports received","reports":3053,"deaths":61,"injuries":922,"malfunctions":2070,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MKJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2026 Q1: 3,051 adverse event reports received by the FDA (38 death, 24 injury, 2,988 malfunction and 1 other).","value":3051,"unit":"device adverse event reports received","reports":3051,"deaths":38,"injuries":24,"malfunctions":2988,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Staple, Implantable (product code GDW), 2026 Q1: 2,965 adverse event reports received by the FDA (9 death, 337 injury, 2,619 malfunction and 0 other).","value":2965,"unit":"device adverse event reports received","reports":2965,"deaths":9,"injuries":337,"malfunctions":2619,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2026 Q1: 2,865 adverse event reports received by the FDA (27 death, 1,564 injury, 1,274 malfunction and 0 other).","value":2865,"unit":"device adverse event reports received","reports":2865,"deaths":27,"injuries":1564,"malfunctions":1274,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2026 Q1: 2,780 adverse event reports received by the FDA (41 death, 1,056 injury, 1,683 malfunction and 0 other).","value":2780,"unit":"device adverse event reports received","reports":2780,"deaths":41,"injuries":1056,"malfunctions":1683,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OYC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2026 Q1: 2,729 adverse event reports received by the FDA (0 death, 52 injury, 2,677 malfunction and 0 other).","value":2729,"unit":"device adverse event reports received","reports":2729,"deaths":0,"injuries":52,"malfunctions":2677,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOQ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2026 Q1: 2,513 adverse event reports received by the FDA (9 death, 166 injury, 2,338 malfunction and 0 other).","value":2513,"unit":"device adverse event reports received","reports":2513,"deaths":9,"injuries":166,"malfunctions":2338,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2026 Q1: 2,447 adverse event reports received by the FDA (1 death, 109 injury, 2,337 malfunction and 0 other).","value":2447,"unit":"device adverse event reports received","reports":2447,"deaths":1,"injuries":109,"malfunctions":2337,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2026 Q1: 2,358 adverse event reports received by the FDA (1 death, 281 injury, 2,076 malfunction and 0 other).","value":2358,"unit":"device adverse event reports received","reports":2358,"deaths":1,"injuries":281,"malfunctions":2076,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSQ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2026 Q1: 2,250 adverse event reports received by the FDA (385 death, 753 injury, 1,112 malfunction and 0 other).","value":2250,"unit":"device adverse event reports received","reports":2250,"deaths":385,"injuries":753,"malfunctions":1112,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2026 Q1: 2,192 adverse event reports received by the FDA (0 death, 44 injury, 2,148 malfunction and 0 other).","value":2192,"unit":"device adverse event reports received","reports":2192,"deaths":0,"injuries":44,"malfunctions":2148,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BSZ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2026 Q1: 2,122 adverse event reports received by the FDA (1 death, 37 injury, 2,084 malfunction and 0 other).","value":2122,"unit":"device adverse event reports received","reports":2122,"deaths":1,"injuries":37,"malfunctions":2084,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FWM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2026 Q1: 2,106 adverse event reports received by the FDA (2 death, 2,081 injury, 23 malfunction and 0 other).","value":2106,"unit":"device adverse event reports received","reports":2106,"deaths":2,"injuries":2081,"malfunctions":23,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NXC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Aligner, Sequential (product code NXC), 2026 Q1: 2,081 adverse event reports received by the FDA (0 death, 2,077 injury, 4 malfunction and 0 other).","value":2081,"unit":"device adverse event reports received","reports":2081,"deaths":0,"injuries":2077,"malfunctions":4,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LKK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2026 Q1: 2,057 adverse event reports received by the FDA (4 death, 593 injury, 1,460 malfunction and 0 other).","value":2057,"unit":"device adverse event reports received","reports":2057,"deaths":4,"injuries":593,"malfunctions":1460,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2026 Q1: 2,039 adverse event reports received by the FDA (7 death, 5 injury, 2,027 malfunction and 0 other).","value":2039,"unit":"device adverse event reports received","reports":2039,"deaths":7,"injuries":5,"malfunctions":2027,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2026 Q1: 1,918 adverse event reports received by the FDA (0 death, 56 injury, 1,862 malfunction and 0 other).","value":1918,"unit":"device adverse event reports received","reports":1918,"deaths":0,"injuries":56,"malfunctions":1862,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2026 Q1: 1,873 adverse event reports received by the FDA (2 death, 297 injury, 1,574 malfunction and 0 other).","value":1873,"unit":"device adverse event reports received","reports":1873,"deaths":2,"injuries":297,"malfunctions":1574,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JWH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2026 Q1: 1,757 adverse event reports received by the FDA (1 death, 1,605 injury, 151 malfunction and 0 other).","value":1757,"unit":"device adverse event reports received","reports":1757,"deaths":1,"injuries":1605,"malfunctions":151,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2026 Q1: 1,700 adverse event reports received by the FDA (4 death, 7 injury, 1,689 malfunction and 0 other).","value":1700,"unit":"device adverse event reports received","reports":1700,"deaths":4,"injuries":7,"malfunctions":1689,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"General Surgery Tray (product code LRO), 2026 Q1: 1,697 adverse event reports received by the FDA (0 death, 57 injury, 1,640 malfunction and 0 other).","value":1697,"unit":"device adverse event reports received","reports":1697,"deaths":0,"injuries":57,"malfunctions":1640,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2026 Q1: 1,623 adverse event reports received by the FDA (219 death, 1,127 injury, 277 malfunction and 0 other).","value":1623,"unit":"device adverse event reports received","reports":1623,"deaths":219,"injuries":1127,"malfunctions":277,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ODG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2026 Q1: 1,582 adverse event reports received by the FDA (0 death, 2 injury, 1,580 malfunction and 0 other).","value":1582,"unit":"device adverse event reports received","reports":1582,"deaths":0,"injuries":2,"malfunctions":1580,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Introducer, Catheter (product code DYB), 2026 Q1: 1,566 adverse event reports received by the FDA (65 death, 450 injury, 1,051 malfunction and 0 other).","value":1566,"unit":"device adverse event reports received","reports":1566,"deaths":65,"injuries":450,"malfunctions":1051,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2026 Q1: 1,557 adverse event reports received by the FDA (0 death, 809 injury, 748 malfunction and 0 other).","value":1557,"unit":"device adverse event reports received","reports":1557,"deaths":0,"injuries":809,"malfunctions":748,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2026 Q1: 1,432 adverse event reports received by the FDA (1 death, 64 injury, 1,367 malfunction and 0 other).","value":1432,"unit":"device adverse event reports received","reports":1432,"deaths":1,"injuries":64,"malfunctions":1367,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MGB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2026 Q1: 1,412 adverse event reports received by the FDA (10 death, 339 injury, 1,063 malfunction and 0 other).","value":1412,"unit":"device adverse event reports received","reports":1412,"deaths":10,"injuries":339,"malfunctions":1063,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SFI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SFI","deviceName":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System (product code SFI), 2026 Q1: 1,390 adverse event reports received by the FDA (0 death, 39 injury, 1,351 malfunction and 0 other).","value":1390,"unit":"device adverse event reports received","reports":1390,"deaths":0,"injuries":39,"malfunctions":1351,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QZI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2026 Q1: 1,366 adverse event reports received by the FDA (42 death, 673 injury, 651 malfunction and 0 other).","value":1366,"unit":"device adverse event reports received","reports":1366,"deaths":42,"injuries":673,"malfunctions":651,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVZ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2026 Q1: 1,347 adverse event reports received by the FDA (46 death, 725 injury, 576 malfunction and 0 other).","value":1347,"unit":"device adverse event reports received","reports":1347,"deaths":46,"injuries":725,"malfunctions":576,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Leadless Pacemaker (product code PNJ), 2026 Q1: 1,310 adverse event reports received by the FDA (86 death, 467 injury, 757 malfunction and 0 other).","value":1310,"unit":"device adverse event reports received","reports":1310,"deaths":86,"injuries":467,"malfunctions":757,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HET:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2026 Q1: 1,305 adverse event reports received by the FDA (0 death, 2 injury, 1,303 malfunction and 0 other).","value":1305,"unit":"device adverse event reports received","reports":1305,"deaths":0,"injuries":2,"malfunctions":1303,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Implant, Cochlear (product code MCM), 2026 Q1: 1,269 adverse event reports received by the FDA (0 death, 832 injury, 437 malfunction and 0 other).","value":1269,"unit":"device adverse event reports received","reports":1269,"deaths":0,"injuries":832,"malfunctions":437,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OWB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2026 Q1: 1,224 adverse event reports received by the FDA (4 death, 23 injury, 1,196 malfunction and 1 other).","value":1224,"unit":"device adverse event reports received","reports":1224,"deaths":4,"injuries":23,"malfunctions":1196,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2026 Q1: 1,221 adverse event reports received by the FDA (6 death, 1,074 injury, 140 malfunction and 1 other).","value":1221,"unit":"device adverse event reports received","reports":1221,"deaths":6,"injuries":1074,"malfunctions":140,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FOZ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2026 Q1: 1,210 adverse event reports received by the FDA (1 death, 66 injury, 1,143 malfunction and 0 other).","value":1210,"unit":"device adverse event reports received","reports":1210,"deaths":1,"injuries":66,"malfunctions":1143,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JKA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2026 Q1: 1,206 adverse event reports received by the FDA (0 death, 17 injury, 1,189 malfunction and 0 other).","value":1206,"unit":"device adverse event reports received","reports":1206,"deaths":0,"injuries":17,"malfunctions":1189,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2026 Q1: 1,199 adverse event reports received by the FDA (33 death, 205 injury, 961 malfunction and 0 other).","value":1199,"unit":"device adverse event reports received","reports":1199,"deaths":33,"injuries":205,"malfunctions":961,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JJE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2026 Q1: 1,187 adverse event reports received by the FDA (0 death, 19 injury, 1,168 malfunction and 0 other).","value":1187,"unit":"device adverse event reports received","reports":1187,"deaths":0,"injuries":19,"malfunctions":1168,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Intraocular Lens (product code HQL), 2026 Q1: 1,185 adverse event reports received by the FDA (0 death, 229 injury, 956 malfunction and 0 other).","value":1185,"unit":"device adverse event reports received","reports":1185,"deaths":0,"injuries":229,"malfunctions":956,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2026 Q1: 1,159 adverse event reports received by the FDA (2 death, 65 injury, 1,092 malfunction and 0 other).","value":1159,"unit":"device adverse event reports received","reports":1159,"deaths":2,"injuries":65,"malfunctions":1092,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2026 Q1: 1,151 adverse event reports received by the FDA (0 death, 18 injury, 1,133 malfunction and 0 other).","value":1151,"unit":"device adverse event reports received","reports":1151,"deaths":0,"injuries":18,"malfunctions":1133,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2026 Q1: 1,082 adverse event reports received by the FDA (0 death, 95 injury, 987 malfunction and 0 other).","value":1082,"unit":"device adverse event reports received","reports":1082,"deaths":0,"injuries":95,"malfunctions":987,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Syringe, Piston (product code FMF), 2026 Q1: 1,037 adverse event reports received by the FDA (1 death, 86 injury, 950 malfunction and 0 other).","value":1037,"unit":"device adverse event reports received","reports":1037,"deaths":1,"injuries":86,"malfunctions":950,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2026 Q1: 1,030 adverse event reports received by the FDA (1 death, 5 injury, 1,024 malfunction and 0 other).","value":1030,"unit":"device adverse event reports received","reports":1030,"deaths":1,"injuries":5,"malfunctions":1024,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2026 Q1: 977 adverse event reports received by the FDA (54 death, 637 injury, 286 malfunction and 0 other).","value":977,"unit":"device adverse event reports received","reports":977,"deaths":54,"injuries":637,"malfunctions":286,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2026 Q1: 977 adverse event reports received by the FDA (0 death, 68 injury, 909 malfunction and 0 other).","value":977,"unit":"device adverse event reports received","reports":977,"deaths":0,"injuries":68,"malfunctions":909,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2026 Q1: 953 adverse event reports received by the FDA (0 death, 17 injury, 936 malfunction and 0 other).","value":953,"unit":"device adverse event reports received","reports":953,"deaths":0,"injuries":17,"malfunctions":936,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2026 Q1: 941 adverse event reports received by the FDA (6 death, 854 injury, 81 malfunction and 0 other).","value":941,"unit":"device adverse event reports received","reports":941,"deaths":6,"injuries":854,"malfunctions":81,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2026 Q1: 934 adverse event reports received by the FDA (0 death, 27 injury, 907 malfunction and 0 other).","value":934,"unit":"device adverse event reports received","reports":934,"deaths":0,"injuries":27,"malfunctions":907,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2026 Q1: 921 adverse event reports received by the FDA (0 death, 149 injury, 772 malfunction and 0 other).","value":921,"unit":"device adverse event reports received","reports":921,"deaths":0,"injuries":149,"malfunctions":772,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NGV:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2026 Q1: 894 adverse event reports received by the FDA (145 death, 721 injury, 28 malfunction and 0 other).","value":894,"unit":"device adverse event reports received","reports":894,"deaths":145,"injuries":721,"malfunctions":28,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2026 Q1: 885 adverse event reports received by the FDA (0 death, 100 injury, 785 malfunction and 0 other).","value":885,"unit":"device adverse event reports received","reports":885,"deaths":0,"injuries":100,"malfunctions":785,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2026 Q1: 864 adverse event reports received by the FDA (0 death, 104 injury, 759 malfunction and 1 other).","value":864,"unit":"device adverse event reports received","reports":864,"deaths":0,"injuries":104,"malfunctions":759,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Instrument, Biopsy (product code KNW), 2026 Q1: 840 adverse event reports received by the FDA (0 death, 59 injury, 781 malfunction and 0 other).","value":840,"unit":"device adverse event reports received","reports":840,"deaths":0,"injuries":59,"malfunctions":781,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2026 Q1: 833 adverse event reports received by the FDA (5 death, 489 injury, 339 malfunction and 0 other).","value":833,"unit":"device adverse event reports received","reports":833,"deaths":5,"injuries":489,"malfunctions":339,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Percutaneous (product code DQY), 2026 Q1: 814 adverse event reports received by the FDA (23 death, 210 injury, 581 malfunction and 0 other).","value":814,"unit":"device adverse event reports received","reports":814,"deaths":23,"injuries":210,"malfunctions":581,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2026 Q1: 796 adverse event reports received by the FDA (0 death, 3 injury, 793 malfunction and 0 other).","value":796,"unit":"device adverse event reports received","reports":796,"deaths":0,"injuries":3,"malfunctions":793,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2026 Q1: 795 adverse event reports received by the FDA (4 death, 454 injury, 337 malfunction and 0 other).","value":795,"unit":"device adverse event reports received","reports":795,"deaths":4,"injuries":454,"malfunctions":337,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PHX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2026 Q1: 795 adverse event reports received by the FDA (0 death, 710 injury, 85 malfunction and 0 other).","value":795,"unit":"device adverse event reports received","reports":795,"deaths":0,"injuries":710,"malfunctions":85,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2026 Q1: 794 adverse event reports received by the FDA (3 death, 382 injury, 409 malfunction and 0 other).","value":794,"unit":"device adverse event reports received","reports":794,"deaths":3,"injuries":382,"malfunctions":409,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MIH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2026 Q1: 747 adverse event reports received by the FDA (39 death, 553 injury, 155 malfunction and 0 other).","value":747,"unit":"device adverse event reports received","reports":747,"deaths":39,"injuries":553,"malfunctions":155,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2026 Q1: 744 adverse event reports received by the FDA (1 death, 4 injury, 739 malfunction and 0 other).","value":744,"unit":"device adverse event reports received","reports":744,"deaths":1,"injuries":4,"malfunctions":739,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2026 Q1: 725 adverse event reports received by the FDA (5 death, 24 injury, 696 malfunction and 0 other).","value":725,"unit":"device adverse event reports received","reports":725,"deaths":5,"injuries":24,"malfunctions":696,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OLO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2026 Q1: 718 adverse event reports received by the FDA (3 death, 66 injury, 649 malfunction and 0 other).","value":718,"unit":"device adverse event reports received","reports":718,"deaths":3,"injuries":66,"malfunctions":649,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2026 Q1: 713 adverse event reports received by the FDA (1 death, 31 injury, 681 malfunction and 0 other).","value":713,"unit":"device adverse event reports received","reports":713,"deaths":1,"injuries":31,"malfunctions":681,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2026 Q1: 699 adverse event reports received by the FDA (0 death, 385 injury, 314 malfunction and 0 other).","value":699,"unit":"device adverse event reports received","reports":699,"deaths":0,"injuries":385,"malfunctions":314,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FKX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2026 Q1: 689 adverse event reports received by the FDA (22 death, 270 injury, 397 malfunction and 0 other).","value":689,"unit":"device adverse event reports received","reports":689,"deaths":22,"injuries":270,"malfunctions":397,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIQ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2026 Q1: 685 adverse event reports received by the FDA (39 death, 278 injury, 368 malfunction and 0 other).","value":685,"unit":"device adverse event reports received","reports":685,"deaths":39,"injuries":278,"malfunctions":368,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2026 Q1: 680 adverse event reports received by the FDA (0 death, 126 injury, 554 malfunction and 0 other).","value":680,"unit":"device adverse event reports received","reports":680,"deaths":0,"injuries":126,"malfunctions":554,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KMY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2026 Q1: 675 adverse event reports received by the FDA (0 death, 671 injury, 4 malfunction and 0 other).","value":675,"unit":"device adverse event reports received","reports":675,"deaths":0,"injuries":671,"malfunctions":4,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2026 Q1: 670 adverse event reports received by the FDA (0 death, 137 injury, 532 malfunction and 1 other).","value":670,"unit":"device adverse event reports received","reports":670,"deaths":0,"injuries":137,"malfunctions":532,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SBA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2026 Q1: 670 adverse event reports received by the FDA (1 death, 134 injury, 535 malfunction and 0 other).","value":670,"unit":"device adverse event reports received","reports":670,"deaths":1,"injuries":134,"malfunctions":535,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2026 Q1: 668 adverse event reports received by the FDA (0 death, 602 injury, 66 malfunction and 0 other).","value":668,"unit":"device adverse event reports received","reports":668,"deaths":0,"injuries":602,"malfunctions":66,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2026 Q1: 664 adverse event reports received by the FDA (0 death, 14 injury, 650 malfunction and 0 other).","value":664,"unit":"device adverse event reports received","reports":664,"deaths":0,"injuries":14,"malfunctions":650,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2026 Q1: 661 adverse event reports received by the FDA (18 death, 56 injury, 587 malfunction and 0 other).","value":661,"unit":"device adverse event reports received","reports":661,"deaths":18,"injuries":56,"malfunctions":587,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2026 Q1: 660 adverse event reports received by the FDA (3 death, 105 injury, 552 malfunction and 0 other).","value":660,"unit":"device adverse event reports received","reports":660,"deaths":3,"injuries":105,"malfunctions":552,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Template (product code HWT), 2026 Q1: 648 adverse event reports received by the FDA (0 death, 1 injury, 647 malfunction and 0 other).","value":648,"unit":"device adverse event reports received","reports":648,"deaths":0,"injuries":1,"malfunctions":647,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2026 Q1: 634 adverse event reports received by the FDA (0 death, 8 injury, 626 malfunction and 0 other).","value":634,"unit":"device adverse event reports received","reports":634,"deaths":0,"injuries":8,"malfunctions":626,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2026 Q1: 634 adverse event reports received by the FDA (2 death, 557 injury, 75 malfunction and 0 other).","value":634,"unit":"device adverse event reports received","reports":634,"deaths":2,"injuries":557,"malfunctions":75,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Steerable (product code DRA), 2026 Q1: 626 adverse event reports received by the FDA (7 death, 173 injury, 446 malfunction and 0 other).","value":626,"unit":"device adverse event reports received","reports":626,"deaths":7,"injuries":173,"malfunctions":446,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MOM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2026 Q1: 593 adverse event reports received by the FDA (0 death, 166 injury, 427 malfunction and 0 other).","value":593,"unit":"device adverse event reports received","reports":593,"deaths":0,"injuries":166,"malfunctions":427,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Clip, Implantable (product code FZP), 2026 Q1: 573 adverse event reports received by the FDA (0 death, 36 injury, 537 malfunction and 0 other).","value":573,"unit":"device adverse event reports received","reports":573,"deaths":0,"injuries":36,"malfunctions":537,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FHW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2026 Q1: 566 adverse event reports received by the FDA (0 death, 507 injury, 59 malfunction and 0 other).","value":566,"unit":"device adverse event reports received","reports":566,"deaths":0,"injuries":507,"malfunctions":59,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2026 Q1: 550 adverse event reports received by the FDA (0 death, 38 injury, 512 malfunction and 0 other).","value":550,"unit":"device adverse event reports received","reports":550,"deaths":0,"injuries":38,"malfunctions":512,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2026 Q1: 539 adverse event reports received by the FDA (0 death, 437 injury, 102 malfunction and 0 other).","value":539,"unit":"device adverse event reports received","reports":539,"deaths":0,"injuries":437,"malfunctions":102,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2026 Q1: 537 adverse event reports received by the FDA (0 death, 18 injury, 519 malfunction and 0 other).","value":537,"unit":"device adverse event reports received","reports":537,"deaths":0,"injuries":18,"malfunctions":519,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NEW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2026 Q1: 537 adverse event reports received by the FDA (0 death, 114 injury, 423 malfunction and 0 other).","value":537,"unit":"device adverse event reports received","reports":537,"deaths":0,"injuries":114,"malfunctions":423,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SCV:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SCV","deviceName":"Modular Electromechanical Surgical System","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Modular Electromechanical Surgical System (product code SCV), 2026 Q1: 533 adverse event reports received by the FDA (0 death, 6 injury, 527 malfunction and 0 other).","value":533,"unit":"device adverse event reports received","reports":533,"deaths":0,"injuries":6,"malfunctions":527,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2026 Q1: 531 adverse event reports received by the FDA (3 death, 250 injury, 278 malfunction and 0 other).","value":531,"unit":"device adverse event reports received","reports":531,"deaths":3,"injuries":250,"malfunctions":278,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PSV:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2026 Q1: 530 adverse event reports received by the FDA (0 death, 14 injury, 516 malfunction and 0 other).","value":530,"unit":"device adverse event reports received","reports":530,"deaths":0,"injuries":14,"malfunctions":516,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NHA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2026 Q1: 527 adverse event reports received by the FDA (0 death, 279 injury, 248 malfunction and 0 other).","value":527,"unit":"device adverse event reports received","reports":527,"deaths":0,"injuries":279,"malfunctions":248,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2026 Q1: 523 adverse event reports received by the FDA (18 death, 179 injury, 325 malfunction and 1 other).","value":523,"unit":"device adverse event reports received","reports":523,"deaths":18,"injuries":179,"malfunctions":325,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2026 Q1: 507 adverse event reports received by the FDA (5 death, 218 injury, 284 malfunction and 0 other).","value":507,"unit":"device adverse event reports received","reports":507,"deaths":5,"injuries":218,"malfunctions":284,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LIT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2026 Q1: 504 adverse event reports received by the FDA (0 death, 35 injury, 469 malfunction and 0 other).","value":504,"unit":"device adverse event reports received","reports":504,"deaths":0,"injuries":35,"malfunctions":469,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2026 Q1: 500 adverse event reports received by the FDA (2 death, 32 injury, 466 malfunction and 0 other).","value":500,"unit":"device adverse event reports received","reports":500,"deaths":2,"injuries":32,"malfunctions":466,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Impactor (product code HWA), 2026 Q1: 493 adverse event reports received by the FDA (0 death, 6 injury, 487 malfunction and 0 other).","value":493,"unit":"device adverse event reports received","reports":493,"deaths":0,"injuries":6,"malfunctions":487,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Thermal Regulating (product code DWJ), 2026 Q1: 488 adverse event reports received by the FDA (0 death, 18 injury, 470 malfunction and 0 other).","value":488,"unit":"device adverse event reports received","reports":488,"deaths":0,"injuries":18,"malfunctions":470,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2026 Q1: 476 adverse event reports received by the FDA (2 death, 76 injury, 398 malfunction and 0 other).","value":476,"unit":"device adverse event reports received","reports":476,"deaths":2,"injuries":76,"malfunctions":398,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Arthroscope (product code HRX), 2026 Q1: 476 adverse event reports received by the FDA (0 death, 17 injury, 459 malfunction and 0 other).","value":476,"unit":"device adverse event reports received","reports":476,"deaths":0,"injuries":17,"malfunctions":459,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PMP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2026 Q1: 468 adverse event reports received by the FDA (0 death, 461 injury, 7 malfunction and 0 other).","value":468,"unit":"device adverse event reports received","reports":468,"deaths":0,"injuries":461,"malfunctions":7,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2026 Q1: 466 adverse event reports received by the FDA (0 death, 13 injury, 453 malfunction and 0 other).","value":466,"unit":"device adverse event reports received","reports":466,"deaths":0,"injuries":13,"malfunctions":453,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OUT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2026 Q1: 466 adverse event reports received by the FDA (17 death, 93 injury, 356 malfunction and 0 other).","value":466,"unit":"device adverse event reports received","reports":466,"deaths":17,"injuries":93,"malfunctions":356,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2026 Q1: 464 adverse event reports received by the FDA (1 death, 89 injury, 374 malfunction and 0 other).","value":464,"unit":"device adverse event reports received","reports":464,"deaths":1,"injuries":89,"malfunctions":374,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2026 Q1: 461 adverse event reports received by the FDA (0 death, 1 injury, 460 malfunction and 0 other).","value":461,"unit":"device adverse event reports received","reports":461,"deaths":0,"injuries":1,"malfunctions":460,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HXX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Screwdriver (product code HXX), 2026 Q1: 457 adverse event reports received by the FDA (0 death, 3 injury, 454 malfunction and 0 other).","value":457,"unit":"device adverse event reports received","reports":457,"deaths":0,"injuries":3,"malfunctions":454,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2026 Q1: 452 adverse event reports received by the FDA (3 death, 24 injury, 425 malfunction and 0 other).","value":452,"unit":"device adverse event reports received","reports":452,"deaths":3,"injuries":24,"malfunctions":425,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2026 Q1: 443 adverse event reports received by the FDA (6 death, 243 injury, 194 malfunction and 0 other).","value":443,"unit":"device adverse event reports received","reports":443,"deaths":6,"injuries":243,"malfunctions":194,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2026 Q1: 441 adverse event reports received by the FDA (1 death, 433 injury, 7 malfunction and 0 other).","value":441,"unit":"device adverse event reports received","reports":441,"deaths":1,"injuries":433,"malfunctions":7,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LHI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2026 Q1: 439 adverse event reports received by the FDA (0 death, 4 injury, 435 malfunction and 0 other).","value":439,"unit":"device adverse event reports received","reports":439,"deaths":0,"injuries":4,"malfunctions":435,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2026 Q1: 433 adverse event reports received by the FDA (18 death, 371 injury, 44 malfunction and 0 other).","value":433,"unit":"device adverse event reports received","reports":433,"deaths":18,"injuries":371,"malfunctions":44,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2026 Q1: 431 adverse event reports received by the FDA (6 death, 165 injury, 260 malfunction and 0 other).","value":431,"unit":"device adverse event reports received","reports":431,"deaths":6,"injuries":165,"malfunctions":260,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2026 Q1: 428 adverse event reports received by the FDA (0 death, 79 injury, 349 malfunction and 0 other).","value":428,"unit":"device adverse event reports received","reports":428,"deaths":0,"injuries":79,"malfunctions":349,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Replacement Heart-Valve (product code DYE), 2026 Q1: 425 adverse event reports received by the FDA (8 death, 387 injury, 29 malfunction and 1 other).","value":425,"unit":"device adverse event reports received","reports":425,"deaths":8,"injuries":387,"malfunctions":29,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LMH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2026 Q1: 420 adverse event reports received by the FDA (0 death, 418 injury, 2 malfunction and 0 other).","value":420,"unit":"device adverse event reports received","reports":420,"deaths":0,"injuries":418,"malfunctions":2,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JDI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2026 Q1: 399 adverse event reports received by the FDA (15 death, 334 injury, 50 malfunction and 0 other).","value":399,"unit":"device adverse event reports received","reports":399,"deaths":15,"injuries":334,"malfunctions":50,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2026 Q1: 397 adverse event reports received by the FDA (3 death, 36 injury, 358 malfunction and 0 other).","value":397,"unit":"device adverse event reports received","reports":397,"deaths":3,"injuries":36,"malfunctions":358,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2026 Q1: 394 adverse event reports received by the FDA (1 death, 65 injury, 328 malfunction and 0 other).","value":394,"unit":"device adverse event reports received","reports":394,"deaths":1,"injuries":65,"malfunctions":328,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LYJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2026 Q1: 391 adverse event reports received by the FDA (19 death, 170 injury, 202 malfunction and 0 other).","value":391,"unit":"device adverse event reports received","reports":391,"deaths":19,"injuries":170,"malfunctions":202,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2026 Q1: 390 adverse event reports received by the FDA (0 death, 12 injury, 378 malfunction and 0 other).","value":390,"unit":"device adverse event reports received","reports":390,"deaths":0,"injuries":12,"malfunctions":378,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2026 Q1: 390 adverse event reports received by the FDA (1 death, 122 injury, 267 malfunction and 0 other).","value":390,"unit":"device adverse event reports received","reports":390,"deaths":1,"injuries":122,"malfunctions":267,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LOX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2026 Q1: 388 adverse event reports received by the FDA (4 death, 38 injury, 346 malfunction and 0 other).","value":388,"unit":"device adverse event reports received","reports":388,"deaths":4,"injuries":38,"malfunctions":346,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTZ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2026 Q1: 382 adverse event reports received by the FDA (5 death, 36 injury, 341 malfunction and 0 other).","value":382,"unit":"device adverse event reports received","reports":382,"deaths":5,"injuries":36,"malfunctions":341,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Bit, Drill (product code HTW), 2026 Q1: 379 adverse event reports received by the FDA (0 death, 20 injury, 359 malfunction and 0 other).","value":379,"unit":"device adverse event reports received","reports":379,"deaths":0,"injuries":20,"malfunctions":359,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Wheelchair, Powered (product code ITI), 2026 Q1: 373 adverse event reports received by the FDA (1 death, 34 injury, 338 malfunction and 0 other).","value":373,"unit":"device adverse event reports received","reports":373,"deaths":1,"injuries":34,"malfunctions":338,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2026 Q1: 369 adverse event reports received by the FDA (0 death, 146 injury, 223 malfunction and 0 other).","value":369,"unit":"device adverse event reports received","reports":369,"deaths":0,"injuries":146,"malfunctions":223,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2026 Q1: 364 adverse event reports received by the FDA (0 death, 274 injury, 90 malfunction and 0 other).","value":364,"unit":"device adverse event reports received","reports":364,"deaths":0,"injuries":274,"malfunctions":90,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OBJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2026 Q1: 364 adverse event reports received by the FDA (1 death, 29 injury, 334 malfunction and 0 other).","value":364,"unit":"device adverse event reports received","reports":364,"deaths":1,"injuries":29,"malfunctions":334,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GBX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Irrigation (product code GBX), 2026 Q1: 355 adverse event reports received by the FDA (0 death, 19 injury, 336 malfunction and 0 other).","value":355,"unit":"device adverse event reports received","reports":355,"deaths":0,"injuries":19,"malfunctions":336,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QCB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2026 Q1: 354 adverse event reports received by the FDA (0 death, 354 injury, 0 malfunction and 0 other).","value":354,"unit":"device adverse event reports received","reports":354,"deaths":0,"injuries":354,"malfunctions":0,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SAF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2026 Q1: 344 adverse event reports received by the FDA (0 death, 27 injury, 317 malfunction and 0 other).","value":344,"unit":"device adverse event reports received","reports":344,"deaths":0,"injuries":27,"malfunctions":317,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NZU:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2026 Q1: 343 adverse event reports received by the FDA (1 death, 131 injury, 211 malfunction and 0 other).","value":343,"unit":"device adverse event reports received","reports":343,"deaths":1,"injuries":131,"malfunctions":211,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2026 Q1: 342 adverse event reports received by the FDA (0 death, 59 injury, 283 malfunction and 0 other).","value":342,"unit":"device adverse event reports received","reports":342,"deaths":0,"injuries":59,"malfunctions":283,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2026 Q1: 340 adverse event reports received by the FDA (6 death, 18 injury, 316 malfunction and 0 other).","value":340,"unit":"device adverse event reports received","reports":340,"deaths":6,"injuries":18,"malfunctions":316,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JCW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2026 Q1: 339 adverse event reports received by the FDA (0 death, 327 injury, 12 malfunction and 0 other).","value":339,"unit":"device adverse event reports received","reports":339,"deaths":0,"injuries":327,"malfunctions":12,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FJK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2026 Q1: 337 adverse event reports received by the FDA (1 death, 13 injury, 323 malfunction and 0 other).","value":337,"unit":"device adverse event reports received","reports":337,"deaths":1,"injuries":13,"malfunctions":323,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2026 Q1: 333 adverse event reports received by the FDA (0 death, 319 injury, 14 malfunction and 0 other).","value":333,"unit":"device adverse event reports received","reports":333,"deaths":0,"injuries":319,"malfunctions":14,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MFK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2026 Q1: 332 adverse event reports received by the FDA (0 death, 196 injury, 136 malfunction and 0 other).","value":332,"unit":"device adverse event reports received","reports":332,"deaths":0,"injuries":196,"malfunctions":136,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IZI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2026 Q1: 318 adverse event reports received by the FDA (2 death, 3 injury, 313 malfunction and 0 other).","value":318,"unit":"device adverse event reports received","reports":318,"deaths":2,"injuries":3,"malfunctions":313,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2026 Q1: 315 adverse event reports received by the FDA (0 death, 164 injury, 151 malfunction and 0 other).","value":315,"unit":"device adverse event reports received","reports":315,"deaths":0,"injuries":164,"malfunctions":151,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2026 Q1: 313 adverse event reports received by the FDA (40 death, 270 injury, 3 malfunction and 0 other).","value":313,"unit":"device adverse event reports received","reports":313,"deaths":40,"injuries":270,"malfunctions":3,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2026 Q1: 311 adverse event reports received by the FDA (9 death, 32 injury, 270 malfunction and 0 other).","value":311,"unit":"device adverse event reports received","reports":311,"deaths":9,"injuries":32,"malfunctions":270,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2026 Q1: 303 adverse event reports received by the FDA (0 death, 1 injury, 302 malfunction and 0 other).","value":303,"unit":"device adverse event reports received","reports":303,"deaths":0,"injuries":1,"malfunctions":302,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2026 Q1: 298 adverse event reports received by the FDA (0 death, 31 injury, 267 malfunction and 0 other).","value":298,"unit":"device adverse event reports received","reports":298,"deaths":0,"injuries":31,"malfunctions":267,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Urethroscope (product code FGC), 2026 Q1: 296 adverse event reports received by the FDA (0 death, 0 injury, 296 malfunction and 0 other).","value":296,"unit":"device adverse event reports received","reports":296,"deaths":0,"injuries":0,"malfunctions":296,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Driver, Prosthesis (product code HWR), 2026 Q1: 295 adverse event reports received by the FDA (0 death, 5 injury, 290 malfunction and 0 other).","value":295,"unit":"device adverse event reports received","reports":295,"deaths":0,"injuries":5,"malfunctions":290,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2026 Q1: 289 adverse event reports received by the FDA (0 death, 0 injury, 289 malfunction and 0 other).","value":289,"unit":"device adverse event reports received","reports":289,"deaths":0,"injuries":0,"malfunctions":289,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNQ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2026 Q1: 288 adverse event reports received by the FDA (0 death, 280 injury, 8 malfunction and 0 other).","value":288,"unit":"device adverse event reports received","reports":288,"deaths":0,"injuries":280,"malfunctions":8,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JXG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2026 Q1: 287 adverse event reports received by the FDA (4 death, 154 injury, 129 malfunction and 0 other).","value":287,"unit":"device adverse event reports received","reports":287,"deaths":4,"injuries":154,"malfunctions":129,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2026 Q1: 286 adverse event reports received by the FDA (1 death, 60 injury, 225 malfunction and 0 other).","value":286,"unit":"device adverse event reports received","reports":286,"deaths":1,"injuries":60,"malfunctions":225,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OAE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2026 Q1: 286 adverse event reports received by the FDA (3 death, 139 injury, 144 malfunction and 0 other).","value":286,"unit":"device adverse event reports received","reports":286,"deaths":3,"injuries":139,"malfunctions":144,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PYX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2026 Q1: 284 adverse event reports received by the FDA (86 death, 120 injury, 78 malfunction and 0 other).","value":284,"unit":"device adverse event reports received","reports":284,"deaths":86,"injuries":120,"malfunctions":78,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KOD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Urological (product code KOD), 2026 Q1: 282 adverse event reports received by the FDA (0 death, 20 injury, 262 malfunction and 0 other).","value":282,"unit":"device adverse event reports received","reports":282,"deaths":0,"injuries":20,"malfunctions":262,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Device, Anti-Snoring (product code LRK), 2026 Q1: 282 adverse event reports received by the FDA (0 death, 18 injury, 264 malfunction and 0 other).","value":282,"unit":"device adverse event reports received","reports":282,"deaths":0,"injuries":18,"malfunctions":264,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Programmer, Pacemaker (product code KRG), 2026 Q1: 278 adverse event reports received by the FDA (0 death, 4 injury, 274 malfunction and 0 other).","value":278,"unit":"device adverse event reports received","reports":278,"deaths":0,"injuries":4,"malfunctions":274,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2026 Q1: 275 adverse event reports received by the FDA (2 death, 27 injury, 246 malfunction and 0 other).","value":275,"unit":"device adverse event reports received","reports":275,"deaths":2,"injuries":27,"malfunctions":246,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PFO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2026 Q1: 275 adverse event reports received by the FDA (0 death, 248 injury, 27 malfunction and 0 other).","value":275,"unit":"device adverse event reports received","reports":275,"deaths":0,"injuries":248,"malfunctions":27,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stapler, Surgical (product code GAG), 2026 Q1: 266 adverse event reports received by the FDA (4 death, 39 injury, 223 malfunction and 0 other).","value":266,"unit":"device adverse event reports received","reports":266,"deaths":4,"injuries":39,"malfunctions":223,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Reamer (product code HTO), 2026 Q1: 264 adverse event reports received by the FDA (0 death, 3 injury, 261 malfunction and 0 other).","value":264,"unit":"device adverse event reports received","reports":264,"deaths":0,"injuries":3,"malfunctions":261,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ERL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2026 Q1: 263 adverse event reports received by the FDA (0 death, 1 injury, 262 malfunction and 0 other).","value":263,"unit":"device adverse event reports received","reports":263,"deaths":0,"injuries":1,"malfunctions":262,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Coude (product code EZC), 2026 Q1: 263 adverse event reports received by the FDA (1 death, 30 injury, 232 malfunction and 0 other).","value":263,"unit":"device adverse event reports received","reports":263,"deaths":1,"injuries":30,"malfunctions":232,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2026 Q1: 259 adverse event reports received by the FDA (4 death, 15 injury, 240 malfunction and 0 other).","value":259,"unit":"device adverse event reports received","reports":259,"deaths":4,"injuries":15,"malfunctions":240,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2026 Q1: 259 adverse event reports received by the FDA (11 death, 105 injury, 143 malfunction and 0 other).","value":259,"unit":"device adverse event reports received","reports":259,"deaths":11,"injuries":105,"malfunctions":143,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2026 Q1: 252 adverse event reports received by the FDA (22 death, 124 injury, 106 malfunction and 0 other).","value":252,"unit":"device adverse event reports received","reports":252,"deaths":22,"injuries":124,"malfunctions":106,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2026 Q1: 251 adverse event reports received by the FDA (0 death, 128 injury, 123 malfunction and 0 other).","value":251,"unit":"device adverse event reports received","reports":251,"deaths":0,"injuries":128,"malfunctions":123,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2026 Q1: 249 adverse event reports received by the FDA (2 death, 2 injury, 245 malfunction and 0 other).","value":249,"unit":"device adverse event reports received","reports":249,"deaths":2,"injuries":2,"malfunctions":245,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2026 Q1: 244 adverse event reports received by the FDA (0 death, 15 injury, 229 malfunction and 0 other).","value":244,"unit":"device adverse event reports received","reports":244,"deaths":0,"injuries":15,"malfunctions":229,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2026 Q1: 242 adverse event reports received by the FDA (0 death, 1 injury, 241 malfunction and 0 other).","value":242,"unit":"device adverse event reports received","reports":242,"deaths":0,"injuries":1,"malfunctions":241,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Oximeter (product code DQA), 2026 Q1: 239 adverse event reports received by the FDA (4 death, 5 injury, 230 malfunction and 0 other).","value":239,"unit":"device adverse event reports received","reports":239,"deaths":4,"injuries":5,"malfunctions":230,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTQ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2026 Q1: 236 adverse event reports received by the FDA (3 death, 2 injury, 231 malfunction and 0 other).","value":236,"unit":"device adverse event reports received","reports":236,"deaths":3,"injuries":2,"malfunctions":231,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2026 Q1: 235 adverse event reports received by the FDA (0 death, 23 injury, 212 malfunction and 0 other).","value":235,"unit":"device adverse event reports received","reports":235,"deaths":0,"injuries":23,"malfunctions":212,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2026 Q1: 233 adverse event reports received by the FDA (10 death, 86 injury, 137 malfunction and 0 other).","value":233,"unit":"device adverse event reports received","reports":233,"deaths":10,"injuries":86,"malfunctions":137,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2026 Q1: 233 adverse event reports received by the FDA (1 death, 11 injury, 221 malfunction and 0 other).","value":233,"unit":"device adverse event reports received","reports":233,"deaths":1,"injuries":11,"malfunctions":221,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2026 Q1: 221 adverse event reports received by the FDA (0 death, 1 injury, 220 malfunction and 0 other).","value":221,"unit":"device adverse event reports received","reports":221,"deaths":0,"injuries":1,"malfunctions":220,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GWF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2026 Q1: 221 adverse event reports received by the FDA (0 death, 4 injury, 217 malfunction and 0 other).","value":221,"unit":"device adverse event reports received","reports":221,"deaths":0,"injuries":4,"malfunctions":217,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MLV:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2026 Q1: 221 adverse event reports received by the FDA (18 death, 68 injury, 135 malfunction and 0 other).","value":221,"unit":"device adverse event reports received","reports":221,"deaths":18,"injuries":68,"malfunctions":135,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MND:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ligator, Esophageal (product code MND), 2026 Q1: 221 adverse event reports received by the FDA (0 death, 26 injury, 195 malfunction and 0 other).","value":221,"unit":"device adverse event reports received","reports":221,"deaths":0,"injuries":26,"malfunctions":195,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2026 Q1: 220 adverse event reports received by the FDA (0 death, 216 injury, 4 malfunction and 0 other).","value":220,"unit":"device adverse event reports received","reports":220,"deaths":0,"injuries":216,"malfunctions":4,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2026 Q1: 217 adverse event reports received by the FDA (0 death, 5 injury, 212 malfunction and 0 other).","value":217,"unit":"device adverse event reports received","reports":217,"deaths":0,"injuries":5,"malfunctions":212,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2026 Q1: 215 adverse event reports received by the FDA (1 death, 206 injury, 8 malfunction and 0 other).","value":215,"unit":"device adverse event reports received","reports":215,"deaths":1,"injuries":206,"malfunctions":8,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2026 Q1: 211 adverse event reports received by the FDA (1 death, 14 injury, 196 malfunction and 0 other).","value":211,"unit":"device adverse event reports received","reports":211,"deaths":1,"injuries":14,"malfunctions":196,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Septostomy (product code DXF), 2026 Q1: 208 adverse event reports received by the FDA (10 death, 161 injury, 37 malfunction and 0 other).","value":208,"unit":"device adverse event reports received","reports":208,"deaths":10,"injuries":161,"malfunctions":37,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FCG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Biopsy Needle (product code FCG), 2026 Q1: 208 adverse event reports received by the FDA (0 death, 22 injury, 186 malfunction and 0 other).","value":208,"unit":"device adverse event reports received","reports":208,"deaths":0,"injuries":22,"malfunctions":186,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NOU:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2026 Q1: 208 adverse event reports received by the FDA (6 death, 13 injury, 189 malfunction and 0 other).","value":208,"unit":"device adverse event reports received","reports":208,"deaths":6,"injuries":13,"malfunctions":189,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LON:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2026 Q1: 206 adverse event reports received by the FDA (0 death, 1 injury, 205 malfunction and 0 other).","value":206,"unit":"device adverse event reports received","reports":206,"deaths":0,"injuries":1,"malfunctions":205,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2026 Q1: 205 adverse event reports received by the FDA (8 death, 129 injury, 68 malfunction and 0 other).","value":205,"unit":"device adverse event reports received","reports":205,"deaths":8,"injuries":129,"malfunctions":68,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JOH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2026 Q1: 204 adverse event reports received by the FDA (2 death, 10 injury, 192 malfunction and 0 other).","value":204,"unit":"device adverse event reports received","reports":204,"deaths":2,"injuries":10,"malfunctions":192,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MMI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2026 Q1: 198 adverse event reports received by the FDA (0 death, 3 injury, 195 malfunction and 0 other).","value":198,"unit":"device adverse event reports received","reports":198,"deaths":0,"injuries":3,"malfunctions":195,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2026 Q1: 192 adverse event reports received by the FDA (0 death, 35 injury, 157 malfunction and 0 other).","value":192,"unit":"device adverse event reports received","reports":192,"deaths":0,"injuries":35,"malfunctions":157,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2026 Q1: 190 adverse event reports received by the FDA (0 death, 2 injury, 188 malfunction and 0 other).","value":190,"unit":"device adverse event reports received","reports":190,"deaths":0,"injuries":2,"malfunctions":188,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stretcher, Wheeled (product code FPO), 2026 Q1: 185 adverse event reports received by the FDA (4 death, 6 injury, 175 malfunction and 0 other).","value":185,"unit":"device adverse event reports received","reports":185,"deaths":4,"injuries":6,"malfunctions":175,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NSA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2026 Q1: 183 adverse event reports received by the FDA (6 death, 3 injury, 174 malfunction and 0 other).","value":183,"unit":"device adverse event reports received","reports":183,"deaths":6,"injuries":3,"malfunctions":174,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2026 Q1: 179 adverse event reports received by the FDA (0 death, 165 injury, 14 malfunction and 0 other).","value":179,"unit":"device adverse event reports received","reports":179,"deaths":0,"injuries":165,"malfunctions":14,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2026 Q1: 179 adverse event reports received by the FDA (17 death, 51 injury, 111 malfunction and 0 other).","value":179,"unit":"device adverse event reports received","reports":179,"deaths":17,"injuries":51,"malfunctions":111,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2026 Q1: 177 adverse event reports received by the FDA (0 death, 2 injury, 175 malfunction and 0 other).","value":177,"unit":"device adverse event reports received","reports":177,"deaths":0,"injuries":2,"malfunctions":175,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2026 Q1: 176 adverse event reports received by the FDA (0 death, 7 injury, 169 malfunction and 0 other).","value":176,"unit":"device adverse event reports received","reports":176,"deaths":0,"injuries":7,"malfunctions":169,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2026 Q1: 173 adverse event reports received by the FDA (3 death, 49 injury, 121 malfunction and 0 other).","value":173,"unit":"device adverse event reports received","reports":173,"deaths":3,"injuries":49,"malfunctions":121,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MTA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2026 Q1: 169 adverse event reports received by the FDA (0 death, 168 injury, 1 malfunction and 0 other).","value":169,"unit":"device adverse event reports received","reports":169,"deaths":0,"injuries":168,"malfunctions":1,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HNN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Knife, Ophthalmic (product code HNN), 2026 Q1: 167 adverse event reports received by the FDA (0 death, 5 injury, 162 malfunction and 0 other).","value":167,"unit":"device adverse event reports received","reports":167,"deaths":0,"injuries":5,"malfunctions":162,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GFD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Dermatome (product code GFD), 2026 Q1: 166 adverse event reports received by the FDA (0 death, 13 injury, 153 malfunction and 0 other).","value":166,"unit":"device adverse event reports received","reports":166,"deaths":0,"injuries":13,"malfunctions":153,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Endoscope, Rigid (product code GCM), 2026 Q1: 161 adverse event reports received by the FDA (0 death, 0 injury, 161 malfunction and 0 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":0,"injuries":0,"malfunctions":161,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2026 Q1: 161 adverse event reports received by the FDA (0 death, 161 injury, 0 malfunction and 0 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":0,"injuries":161,"malfunctions":0,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2026 Q1: 155 adverse event reports received by the FDA (0 death, 147 injury, 8 malfunction and 0 other).","value":155,"unit":"device adverse event reports received","reports":155,"deaths":0,"injuries":147,"malfunctions":8,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2026 Q1: 154 adverse event reports received by the FDA (0 death, 0 injury, 154 malfunction and 0 other).","value":154,"unit":"device adverse event reports received","reports":154,"deaths":0,"injuries":0,"malfunctions":154,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Plate, Bone (product code JEY), 2026 Q1: 151 adverse event reports received by the FDA (0 death, 41 injury, 110 malfunction and 0 other).","value":151,"unit":"device adverse event reports received","reports":151,"deaths":0,"injuries":41,"malfunctions":110,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2026 Q1: 148 adverse event reports received by the FDA (2 death, 9 injury, 135 malfunction and 2 other).","value":148,"unit":"device adverse event reports received","reports":148,"deaths":2,"injuries":9,"malfunctions":135,"other":2,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2026 Q1: 147 adverse event reports received by the FDA (0 death, 146 injury, 1 malfunction and 0 other).","value":147,"unit":"device adverse event reports received","reports":147,"deaths":0,"injuries":146,"malfunctions":1,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2026 Q1: 146 adverse event reports received by the FDA (6 death, 17 injury, 122 malfunction and 1 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":6,"injuries":17,"malfunctions":122,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2026 Q1: 145 adverse event reports received by the FDA (0 death, 5 injury, 140 malfunction and 0 other).","value":145,"unit":"device adverse event reports received","reports":145,"deaths":0,"injuries":5,"malfunctions":140,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2026 Q1: 143 adverse event reports received by the FDA (0 death, 0 injury, 143 malfunction and 0 other).","value":143,"unit":"device adverse event reports received","reports":143,"deaths":0,"injuries":0,"malfunctions":143,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2026 Q1: 143 adverse event reports received by the FDA (0 death, 3 injury, 140 malfunction and 0 other).","value":143,"unit":"device adverse event reports received","reports":143,"deaths":0,"injuries":3,"malfunctions":140,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAD:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stent, Ureteral (product code FAD), 2026 Q1: 141 adverse event reports received by the FDA (0 death, 33 injury, 108 malfunction and 0 other).","value":141,"unit":"device adverse event reports received","reports":141,"deaths":0,"injuries":33,"malfunctions":108,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2026 Q1: 140 adverse event reports received by the FDA (0 death, 55 injury, 85 malfunction and 0 other).","value":140,"unit":"device adverse event reports received","reports":140,"deaths":0,"injuries":55,"malfunctions":85,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2026 Q1: 138 adverse event reports received by the FDA (16 death, 80 injury, 42 malfunction and 0 other).","value":138,"unit":"device adverse event reports received","reports":138,"deaths":16,"injuries":80,"malfunctions":42,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQK:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2026 Q1: 138 adverse event reports received by the FDA (0 death, 10 injury, 128 malfunction and 0 other).","value":138,"unit":"device adverse event reports received","reports":138,"deaths":0,"injuries":10,"malfunctions":128,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2026 Q1: 136 adverse event reports received by the FDA (0 death, 28 injury, 108 malfunction and 0 other).","value":136,"unit":"device adverse event reports received","reports":136,"deaths":0,"injuries":28,"malfunctions":108,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2026 Q1: 136 adverse event reports received by the FDA (0 death, 7 injury, 129 malfunction and 0 other).","value":136,"unit":"device adverse event reports received","reports":136,"deaths":0,"injuries":7,"malfunctions":129,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HHS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2026 Q1: 135 adverse event reports received by the FDA (0 death, 135 injury, 0 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":0,"injuries":135,"malfunctions":0,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2026 Q1: 132 adverse event reports received by the FDA (0 death, 4 injury, 128 malfunction and 0 other).","value":132,"unit":"device adverse event reports received","reports":132,"deaths":0,"injuries":4,"malfunctions":128,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MRM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2026 Q1: 132 adverse event reports received by the FDA (2 death, 80 injury, 50 malfunction and 0 other).","value":132,"unit":"device adverse event reports received","reports":132,"deaths":2,"injuries":80,"malfunctions":50,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2026 Q1: 131 adverse event reports received by the FDA (0 death, 16 injury, 115 malfunction and 0 other).","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":16,"malfunctions":115,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ETN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Nerve (product code ETN), 2026 Q1: 131 adverse event reports received by the FDA (0 death, 5 injury, 126 malfunction and 0 other).","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":5,"malfunctions":126,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stent, Iliac (product code NIO), 2026 Q1: 128 adverse event reports received by the FDA (3 death, 39 injury, 86 malfunction and 0 other).","value":128,"unit":"device adverse event reports received","reports":128,"deaths":3,"injuries":39,"malfunctions":86,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PRL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2026 Q1: 128 adverse event reports received by the FDA (1 death, 46 injury, 81 malfunction and 0 other).","value":128,"unit":"device adverse event reports received","reports":128,"deaths":1,"injuries":46,"malfunctions":81,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HCG:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2026 Q1: 125 adverse event reports received by the FDA (0 death, 24 injury, 101 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":24,"malfunctions":101,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2026 Q1: 124 adverse event reports received by the FDA (0 death, 1 injury, 123 malfunction and 0 other).","value":124,"unit":"device adverse event reports received","reports":124,"deaths":0,"injuries":1,"malfunctions":123,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Clamp, Vascular (product code DXC), 2026 Q1: 121 adverse event reports received by the FDA (1 death, 16 injury, 104 malfunction and 0 other).","value":121,"unit":"device adverse event reports received","reports":121,"deaths":1,"injuries":16,"malfunctions":104,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GZF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2026 Q1: 121 adverse event reports received by the FDA (1 death, 119 injury, 1 malfunction and 0 other).","value":121,"unit":"device adverse event reports received","reports":121,"deaths":1,"injuries":119,"malfunctions":1,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FQH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Lavage, Jet (product code FQH), 2026 Q1: 120 adverse event reports received by the FDA (0 death, 5 injury, 115 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":0,"injuries":5,"malfunctions":115,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2026 Q1: 120 adverse event reports received by the FDA (0 death, 92 injury, 28 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":0,"injuries":92,"malfunctions":28,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2026 Q1: 119 adverse event reports received by the FDA (0 death, 12 injury, 107 malfunction and 0 other).","value":119,"unit":"device adverse event reports received","reports":119,"deaths":0,"injuries":12,"malfunctions":107,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFL:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2026 Q1: 118 adverse event reports received by the FDA (0 death, 6 injury, 112 malfunction and 0 other).","value":118,"unit":"device adverse event reports received","reports":118,"deaths":0,"injuries":6,"malfunctions":112,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2026 Q1: 118 adverse event reports received by the FDA (0 death, 2 injury, 116 malfunction and 0 other).","value":118,"unit":"device adverse event reports received","reports":118,"deaths":0,"injuries":2,"malfunctions":116,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QHJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2026 Q1: 118 adverse event reports received by the FDA (0 death, 55 injury, 63 malfunction and 0 other).","value":118,"unit":"device adverse event reports received","reports":118,"deaths":0,"injuries":55,"malfunctions":63,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HEB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2026 Q1: 114 adverse event reports received by the FDA (0 death, 2 injury, 112 malfunction and 0 other).","value":114,"unit":"device adverse event reports received","reports":114,"deaths":0,"injuries":2,"malfunctions":112,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NRY:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2026 Q1: 114 adverse event reports received by the FDA (11 death, 22 injury, 81 malfunction and 0 other).","value":114,"unit":"device adverse event reports received","reports":114,"deaths":11,"injuries":22,"malfunctions":81,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2026 Q1: 113 adverse event reports received by the FDA (0 death, 6 injury, 107 malfunction and 0 other).","value":113,"unit":"device adverse event reports received","reports":113,"deaths":0,"injuries":6,"malfunctions":107,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2026 Q1: 111 adverse event reports received by the FDA (0 death, 111 injury, 0 malfunction and 0 other).","value":111,"unit":"device adverse event reports received","reports":111,"deaths":0,"injuries":111,"malfunctions":0,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONU:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2026 Q1: 111 adverse event reports received by the FDA (2 death, 50 injury, 59 malfunction and 0 other).","value":111,"unit":"device adverse event reports received","reports":111,"deaths":2,"injuries":50,"malfunctions":59,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KGX:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2026 Q1: 110 adverse event reports received by the FDA (0 death, 73 injury, 37 malfunction and 0 other).","value":110,"unit":"device adverse event reports received","reports":110,"deaths":0,"injuries":73,"malfunctions":37,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LNH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2026 Q1: 109 adverse event reports received by the FDA (0 death, 38 injury, 71 malfunction and 0 other).","value":109,"unit":"device adverse event reports received","reports":109,"deaths":0,"injuries":38,"malfunctions":71,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKU:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2026 Q1: 108 adverse event reports received by the FDA (0 death, 1 injury, 107 malfunction and 0 other).","value":108,"unit":"device adverse event reports received","reports":108,"deaths":0,"injuries":1,"malfunctions":107,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Calculator, Drug Dose (product code NDC), 2026 Q1: 106 adverse event reports received by the FDA (0 death, 0 injury, 106 malfunction and 0 other).","value":106,"unit":"device adverse event reports received","reports":106,"deaths":0,"injuries":0,"malfunctions":106,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2026 Q1: 104 adverse event reports received by the FDA (4 death, 8 injury, 92 malfunction and 0 other).","value":104,"unit":"device adverse event reports received","reports":104,"deaths":4,"injuries":8,"malfunctions":92,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Stent, Carotid (product code NIM), 2026 Q1: 101 adverse event reports received by the FDA (4 death, 54 injury, 43 malfunction and 0 other).","value":101,"unit":"device adverse event reports received","reports":101,"deaths":4,"injuries":54,"malfunctions":43,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2026 Q1: 99 adverse event reports received by the FDA (0 death, 0 injury, 99 malfunction and 0 other).","value":99,"unit":"device adverse event reports received","reports":99,"deaths":0,"injuries":0,"malfunctions":99,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Blood Culturing (product code MDB), 2026 Q1: 98 adverse event reports received by the FDA (0 death, 0 injury, 98 malfunction and 0 other).","value":98,"unit":"device adverse event reports received","reports":98,"deaths":0,"injuries":0,"malfunctions":98,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2026 Q1: 97 adverse event reports received by the FDA (2 death, 43 injury, 52 malfunction and 0 other).","value":97,"unit":"device adverse event reports received","reports":97,"deaths":2,"injuries":43,"malfunctions":52,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2026 Q1: 95 adverse event reports received by the FDA (0 death, 3 injury, 92 malfunction and 0 other).","value":95,"unit":"device adverse event reports received","reports":95,"deaths":0,"injuries":3,"malfunctions":92,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LCJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2026 Q1: 93 adverse event reports received by the FDA (0 death, 72 injury, 20 malfunction and 1 other).","value":93,"unit":"device adverse event reports received","reports":93,"deaths":0,"injuries":72,"malfunctions":20,"other":1,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OCW:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2026 Q1: 93 adverse event reports received by the FDA (0 death, 26 injury, 67 malfunction and 0 other).","value":93,"unit":"device adverse event reports received","reports":93,"deaths":0,"injuries":26,"malfunctions":67,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FSA:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2026 Q1: 92 adverse event reports received by the FDA (9 death, 24 injury, 59 malfunction and 0 other).","value":92,"unit":"device adverse event reports received","reports":92,"deaths":9,"injuries":24,"malfunctions":59,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:POE:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2026 Q1: 89 adverse event reports received by the FDA (0 death, 52 injury, 37 malfunction and 0 other).","value":89,"unit":"device adverse event reports received","reports":89,"deaths":0,"injuries":52,"malfunctions":37,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBB:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2026 Q1: 87 adverse event reports received by the FDA (0 death, 3 injury, 84 malfunction and 0 other).","value":87,"unit":"device adverse event reports received","reports":87,"deaths":0,"injuries":3,"malfunctions":84,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GIM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2026 Q1: 82 adverse event reports received by the FDA (0 death, 0 injury, 82 malfunction and 0 other).","value":82,"unit":"device adverse event reports received","reports":82,"deaths":0,"injuries":0,"malfunctions":82,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MZF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Test, Hiv Detection (product code MZF), 2026 Q1: 73 adverse event reports received by the FDA (0 death, 0 injury, 73 malfunction and 0 other).","value":73,"unit":"device adverse event reports received","reports":73,"deaths":0,"injuries":0,"malfunctions":73,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXN:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2026 Q1: 70 adverse event reports received by the FDA (0 death, 2 injury, 68 malfunction and 0 other).","value":70,"unit":"device adverse event reports received","reports":70,"deaths":0,"injuries":2,"malfunctions":68,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KTT:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2026 Q1: 70 adverse event reports received by the FDA (0 death, 35 injury, 35 malfunction and 0 other).","value":70,"unit":"device adverse event reports received","reports":70,"deaths":0,"injuries":35,"malfunctions":35,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEQ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Toothbrush, Powered (product code JEQ), 2026 Q1: 66 adverse event reports received by the FDA (0 death, 2 injury, 64 malfunction and 0 other).","value":66,"unit":"device adverse event reports received","reports":66,"deaths":0,"injuries":2,"malfunctions":64,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QKP:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2026 Q1: 57 adverse event reports received by the FDA (0 death, 2 injury, 55 malfunction and 0 other).","value":57,"unit":"device adverse event reports received","reports":57,"deaths":0,"injuries":2,"malfunctions":55,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Compressor, Air, Portable (product code BTI), 2026 Q1: 56 adverse event reports received by the FDA (0 death, 9 injury, 47 malfunction and 0 other).","value":56,"unit":"device adverse event reports received","reports":56,"deaths":0,"injuries":9,"malfunctions":47,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Bariatric Bed (product code OSI), 2026 Q1: 52 adverse event reports received by the FDA (0 death, 1 injury, 51 malfunction and 0 other).","value":52,"unit":"device adverse event reports received","reports":52,"deaths":0,"injuries":1,"malfunctions":51,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAF:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2026 Q1: 41 adverse event reports received by the FDA (3 death, 4 injury, 34 malfunction and 0 other).","value":41,"unit":"device adverse event reports received","reports":41,"deaths":3,"injuries":4,"malfunctions":34,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITJ:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Walker, Mechanical (product code ITJ), 2026 Q1: 36 adverse event reports received by the FDA (0 death, 30 injury, 6 malfunction and 0 other).","value":36,"unit":"device adverse event reports received","reports":36,"deaths":0,"injuries":30,"malfunctions":6,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJH:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Orthopedic Tray (product code OJH), 2026 Q1: 26 adverse event reports received by the FDA (0 death, 4 injury, 22 malfunction and 0 other).","value":26,"unit":"device adverse event reports received","reports":26,"deaths":0,"injuries":4,"malfunctions":22,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNM:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2026 Q1: 22 adverse event reports received by the FDA (1 death, 9 injury, 12 malfunction and 0 other).","value":22,"unit":"device adverse event reports received","reports":22,"deaths":1,"injuries":9,"malfunctions":12,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTC:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTC","deviceName":"Analyzer, Pacemaker Generator Function","specialty":"Cardiovascular","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Analyzer, Pacemaker Generator Function (product code DTC), 2026 Q1: 15 adverse event reports received by the FDA (0 death, 0 injury, 15 malfunction and 0 other).","value":15,"unit":"device adverse event reports received","reports":15,"deaths":0,"injuries":0,"malfunctions":15,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IOR:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2026 Q1: 14 adverse event reports received by the FDA (0 death, 10 injury, 4 malfunction and 0 other).","value":14,"unit":"device adverse event reports received","reports":14,"deaths":0,"injuries":10,"malfunctions":4,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ILS:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Adaptor, Hygiene (product code ILS), 2026 Q1: 8 adverse event reports received by the FDA (0 death, 6 injury, 2 malfunction and 0 other).","value":8,"unit":"device adverse event reports received","reports":8,"deaths":0,"injuries":6,"malfunctions":2,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NQO:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NQO","deviceName":"Prosthesis, Spinous Process Spacer/Plate","specialty":"Unknown","deviceClass":"3","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Prosthesis, Spinous Process Spacer/Plate (product code NQO), 2026 Q1: 7 adverse event reports received by the FDA (0 death, 6 injury, 1 malfunction and 0 other).","value":7,"unit":"device adverse event reports received","reports":7,"deaths":0,"injuries":6,"malfunctions":1,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LLI:2026Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LLI","deviceName":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use","specialty":"General Hospital","deviceClass":"2","quarter":"2026Q1","year":2026,"qtr":1,"periodStart":"2026-01-01","periodEnd":"2026-03-31","status":"P","text":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (product code LLI), 2026 Q1: 6 adverse event reports received by the FDA (2 death, 1 injury, 3 malfunction and 0 other).","value":6,"unit":"device adverse event reports received","reports":6,"deaths":2,"injuries":1,"malfunctions":3,"other":0,"effectiveFrom":"2026-01-01","effectiveTo":"2026-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DZE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2025 Q4: 196,615 adverse event reports received by the FDA (0 death, 196,057 injury, 557 malfunction and 1 other).","value":196615,"unit":"device adverse event reports received","reports":196615,"deaths":0,"injuries":196057,"malfunctions":557,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QFG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2025 Q4: 96,683 adverse event reports received by the FDA (22 death, 11,630 injury, 85,030 malfunction and 1 other).","value":96683,"unit":"device adverse event reports received","reports":96683,"deaths":22,"injuries":11630,"malfunctions":85030,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2025 Q4: 87,394 adverse event reports received by the FDA (40 death, 3,597 injury, 83,756 malfunction and 1 other).","value":87394,"unit":"device adverse event reports received","reports":87394,"deaths":40,"injuries":3597,"malfunctions":83756,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2025 Q4: 36,786 adverse event reports received by the FDA (27 death, 4,541 injury, 32,218 malfunction and 0 other).","value":36786,"unit":"device adverse event reports received","reports":36786,"deaths":27,"injuries":4541,"malfunctions":32218,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BRY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2025 Q4: 19,519 adverse event reports received by the FDA (1 death, 0 injury, 19,518 malfunction and 0 other).","value":19519,"unit":"device adverse event reports received","reports":19519,"deaths":1,"injuries":0,"malfunctions":19518,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FRN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pump, Infusion (product code FRN), 2025 Q4: 12,875 adverse event reports received by the FDA (39 death, 172 injury, 12,663 malfunction and 1 other).","value":12875,"unit":"device adverse event reports received","reports":12875,"deaths":39,"injuries":172,"malfunctions":12663,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PQF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2025 Q4: 10,202 adverse event reports received by the FDA (0 death, 11 injury, 10,191 malfunction and 0 other).","value":10202,"unit":"device adverse event reports received","reports":10202,"deaths":0,"injuries":11,"malfunctions":10191,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2025 Q4: 9,893 adverse event reports received by the FDA (29 death, 508 injury, 9,355 malfunction and 1 other).","value":9893,"unit":"device adverse event reports received","reports":9893,"deaths":29,"injuries":508,"malfunctions":9355,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BZD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2025 Q4: 9,654 adverse event reports received by the FDA (59 death, 75 injury, 9,519 malfunction and 1 other).","value":9654,"unit":"device adverse event reports received","reports":9654,"deaths":59,"injuries":75,"malfunctions":9519,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2025 Q4: 9,313 adverse event reports received by the FDA (0 death, 31 injury, 9,282 malfunction and 0 other).","value":9313,"unit":"device adverse event reports received","reports":9313,"deaths":0,"injuries":31,"malfunctions":9282,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2025 Q4: 8,395 adverse event reports received by the FDA (0 death, 8,259 injury, 135 malfunction and 1 other).","value":8395,"unit":"device adverse event reports received","reports":8395,"deaths":0,"injuries":8259,"malfunctions":135,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2025 Q4: 8,392 adverse event reports received by the FDA (0 death, 12 injury, 8,380 malfunction and 0 other).","value":8392,"unit":"device adverse event reports received","reports":8392,"deaths":0,"injuries":12,"malfunctions":8380,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LGW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2025 Q4: 8,007 adverse event reports received by the FDA (13 death, 6,373 injury, 1,620 malfunction and 1 other).","value":8007,"unit":"device adverse event reports received","reports":8007,"deaths":13,"injuries":6373,"malfunctions":1620,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2025 Q4: 7,978 adverse event reports received by the FDA (0 death, 9 injury, 7,969 malfunction and 0 other).","value":7978,"unit":"device adverse event reports received","reports":7978,"deaths":0,"injuries":9,"malfunctions":7969,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2025 Q4: 6,884 adverse event reports received by the FDA (6 death, 1,539 injury, 5,337 malfunction and 2 other).","value":6884,"unit":"device adverse event reports received","reports":6884,"deaths":6,"injuries":1539,"malfunctions":5337,"other":2,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2025 Q4: 6,036 adverse event reports received by the FDA (66 death, 3,400 injury, 2,568 malfunction and 2 other).","value":6036,"unit":"device adverse event reports received","reports":6036,"deaths":66,"injuries":3400,"malfunctions":2568,"other":2,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2025 Q4: 6,017 adverse event reports received by the FDA (58 death, 2,541 injury, 3,418 malfunction and 0 other).","value":6017,"unit":"device adverse event reports received","reports":6017,"deaths":58,"injuries":2541,"malfunctions":3418,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2025 Q4: 5,968 adverse event reports received by the FDA (54 death, 3,162 injury, 2,750 malfunction and 2 other).","value":5968,"unit":"device adverse event reports received","reports":5968,"deaths":54,"injuries":3162,"malfunctions":2750,"other":2,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2025 Q4: 4,248 adverse event reports received by the FDA (27 death, 2,621 injury, 1,600 malfunction and 0 other).","value":4248,"unit":"device adverse event reports received","reports":4248,"deaths":27,"injuries":2621,"malfunctions":1600,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OWB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2025 Q4: 4,245 adverse event reports received by the FDA (2 death, 14 injury, 4,228 malfunction and 1 other).","value":4245,"unit":"device adverse event reports received","reports":4245,"deaths":2,"injuries":14,"malfunctions":4228,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FET:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2025 Q4: 4,235 adverse event reports received by the FDA (0 death, 18 injury, 4,217 malfunction and 0 other).","value":4235,"unit":"device adverse event reports received","reports":4235,"deaths":0,"injuries":18,"malfunctions":4217,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MKJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2025 Q4: 3,562 adverse event reports received by the FDA (32 death, 44 injury, 3,485 malfunction and 1 other).","value":3562,"unit":"device adverse event reports received","reports":3562,"deaths":32,"injuries":44,"malfunctions":3485,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2025 Q4: 3,454 adverse event reports received by the FDA (317 death, 2,436 injury, 701 malfunction and 0 other).","value":3454,"unit":"device adverse event reports received","reports":3454,"deaths":317,"injuries":2436,"malfunctions":701,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CBK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2025 Q4: 3,237 adverse event reports received by the FDA (18 death, 76 injury, 3,142 malfunction and 1 other).","value":3237,"unit":"device adverse event reports received","reports":3237,"deaths":18,"injuries":76,"malfunctions":3142,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MVK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2025 Q4: 3,233 adverse event reports received by the FDA (74 death, 834 injury, 2,325 malfunction and 0 other).","value":3233,"unit":"device adverse event reports received","reports":3233,"deaths":74,"injuries":834,"malfunctions":2325,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2025 Q4: 3,052 adverse event reports received by the FDA (1 death, 142 injury, 2,909 malfunction and 0 other).","value":3052,"unit":"device adverse event reports received","reports":3052,"deaths":1,"injuries":142,"malfunctions":2909,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Staple, Implantable (product code GDW), 2025 Q4: 2,925 adverse event reports received by the FDA (7 death, 328 injury, 2,590 malfunction and 0 other).","value":2925,"unit":"device adverse event reports received","reports":2925,"deaths":7,"injuries":328,"malfunctions":2590,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2025 Q4: 2,807 adverse event reports received by the FDA (27 death, 1,415 injury, 1,365 malfunction and 0 other).","value":2807,"unit":"device adverse event reports received","reports":2807,"deaths":27,"injuries":1415,"malfunctions":1365,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OYC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2025 Q4: 2,787 adverse event reports received by the FDA (0 death, 13 injury, 2,774 malfunction and 0 other).","value":2787,"unit":"device adverse event reports received","reports":2787,"deaths":0,"injuries":13,"malfunctions":2774,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QLG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2025 Q4: 2,760 adverse event reports received by the FDA (2 death, 478 injury, 2,280 malfunction and 0 other).","value":2760,"unit":"device adverse event reports received","reports":2760,"deaths":2,"injuries":478,"malfunctions":2280,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2025 Q4: 2,741 adverse event reports received by the FDA (52 death, 1,102 injury, 1,587 malfunction and 0 other).","value":2741,"unit":"device adverse event reports received","reports":2741,"deaths":52,"injuries":1102,"malfunctions":1587,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2025 Q4: 2,566 adverse event reports received by the FDA (488 death, 1,287 injury, 791 malfunction and 0 other).","value":2566,"unit":"device adverse event reports received","reports":2566,"deaths":488,"injuries":1287,"malfunctions":791,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2025 Q4: 2,538 adverse event reports received by the FDA (0 death, 229 injury, 2,309 malfunction and 0 other).","value":2538,"unit":"device adverse event reports received","reports":2538,"deaths":0,"injuries":229,"malfunctions":2309,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSQ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2025 Q4: 2,374 adverse event reports received by the FDA (443 death, 801 injury, 1,130 malfunction and 0 other).","value":2374,"unit":"device adverse event reports received","reports":2374,"deaths":443,"injuries":801,"malfunctions":1130,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ODG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2025 Q4: 2,373 adverse event reports received by the FDA (2 death, 2 injury, 2,369 malfunction and 0 other).","value":2373,"unit":"device adverse event reports received","reports":2373,"deaths":2,"injuries":2,"malfunctions":2369,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BSZ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2025 Q4: 2,332 adverse event reports received by the FDA (0 death, 13 injury, 2,319 malfunction and 0 other).","value":2332,"unit":"device adverse event reports received","reports":2332,"deaths":0,"injuries":13,"malfunctions":2319,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKU:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2025 Q4: 2,323 adverse event reports received by the FDA (0 death, 1 injury, 2,322 malfunction and 0 other).","value":2323,"unit":"device adverse event reports received","reports":2323,"deaths":0,"injuries":1,"malfunctions":2322,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOQ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2025 Q4: 2,261 adverse event reports received by the FDA (8 death, 201 injury, 2,052 malfunction and 0 other).","value":2261,"unit":"device adverse event reports received","reports":2261,"deaths":8,"injuries":201,"malfunctions":2052,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JWH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2025 Q4: 2,199 adverse event reports received by the FDA (0 death, 1,958 injury, 241 malfunction and 0 other).","value":2199,"unit":"device adverse event reports received","reports":2199,"deaths":0,"injuries":1958,"malfunctions":241,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FWM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2025 Q4: 2,137 adverse event reports received by the FDA (0 death, 2,115 injury, 22 malfunction and 0 other).","value":2137,"unit":"device adverse event reports received","reports":2137,"deaths":0,"injuries":2115,"malfunctions":22,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2025 Q4: 2,035 adverse event reports received by the FDA (6 death, 22 injury, 2,007 malfunction and 0 other).","value":2035,"unit":"device adverse event reports received","reports":2035,"deaths":6,"injuries":22,"malfunctions":2007,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"General Surgery Tray (product code LRO), 2025 Q4: 2,034 adverse event reports received by the FDA (0 death, 102 injury, 1,932 malfunction and 0 other).","value":2034,"unit":"device adverse event reports received","reports":2034,"deaths":0,"injuries":102,"malfunctions":1932,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2025 Q4: 2,011 adverse event reports received by the FDA (4 death, 342 injury, 1,664 malfunction and 1 other).","value":2011,"unit":"device adverse event reports received","reports":2011,"deaths":4,"injuries":342,"malfunctions":1664,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MGB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2025 Q4: 1,918 adverse event reports received by the FDA (12 death, 686 injury, 1,220 malfunction and 0 other).","value":1918,"unit":"device adverse event reports received","reports":1918,"deaths":12,"injuries":686,"malfunctions":1220,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2025 Q4: 1,852 adverse event reports received by the FDA (1 death, 1,035 injury, 816 malfunction and 0 other).","value":1852,"unit":"device adverse event reports received","reports":1852,"deaths":1,"injuries":1035,"malfunctions":816,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JKA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2025 Q4: 1,792 adverse event reports received by the FDA (0 death, 13 injury, 1,779 malfunction and 0 other).","value":1792,"unit":"device adverse event reports received","reports":1792,"deaths":0,"injuries":13,"malfunctions":1779,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2025 Q4: 1,768 adverse event reports received by the FDA (3 death, 42 injury, 1,723 malfunction and 0 other).","value":1768,"unit":"device adverse event reports received","reports":1768,"deaths":3,"injuries":42,"malfunctions":1723,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2025 Q4: 1,664 adverse event reports received by the FDA (1 death, 1,483 injury, 180 malfunction and 0 other).","value":1664,"unit":"device adverse event reports received","reports":1664,"deaths":1,"injuries":1483,"malfunctions":180,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2025 Q4: 1,627 adverse event reports received by the FDA (1 death, 56 injury, 1,570 malfunction and 0 other).","value":1627,"unit":"device adverse event reports received","reports":1627,"deaths":1,"injuries":56,"malfunctions":1570,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2025 Q4: 1,561 adverse event reports received by the FDA (0 death, 102 injury, 1,459 malfunction and 0 other).","value":1561,"unit":"device adverse event reports received","reports":1561,"deaths":0,"injuries":102,"malfunctions":1459,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2025 Q4: 1,474 adverse event reports received by the FDA (0 death, 34 injury, 1,440 malfunction and 0 other).","value":1474,"unit":"device adverse event reports received","reports":1474,"deaths":0,"injuries":34,"malfunctions":1440,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Implant, Cochlear (product code MCM), 2025 Q4: 1,443 adverse event reports received by the FDA (1 death, 873 injury, 569 malfunction and 0 other).","value":1443,"unit":"device adverse event reports received","reports":1443,"deaths":1,"injuries":873,"malfunctions":569,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HET:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2025 Q4: 1,422 adverse event reports received by the FDA (0 death, 0 injury, 1,422 malfunction and 0 other).","value":1422,"unit":"device adverse event reports received","reports":1422,"deaths":0,"injuries":0,"malfunctions":1422,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LKK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2025 Q4: 1,418 adverse event reports received by the FDA (0 death, 597 injury, 820 malfunction and 1 other).","value":1418,"unit":"device adverse event reports received","reports":1418,"deaths":0,"injuries":597,"malfunctions":820,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Introducer, Catheter (product code DYB), 2025 Q4: 1,406 adverse event reports received by the FDA (62 death, 354 injury, 990 malfunction and 0 other).","value":1406,"unit":"device adverse event reports received","reports":1406,"deaths":62,"injuries":354,"malfunctions":990,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2025 Q4: 1,390 adverse event reports received by the FDA (66 death, 1,012 injury, 312 malfunction and 0 other).","value":1390,"unit":"device adverse event reports received","reports":1390,"deaths":66,"injuries":1012,"malfunctions":312,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVZ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2025 Q4: 1,384 adverse event reports received by the FDA (34 death, 717 injury, 633 malfunction and 0 other).","value":1384,"unit":"device adverse event reports received","reports":1384,"deaths":34,"injuries":717,"malfunctions":633,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Intraocular Lens (product code HQL), 2025 Q4: 1,366 adverse event reports received by the FDA (0 death, 301 injury, 1,064 malfunction and 1 other).","value":1366,"unit":"device adverse event reports received","reports":1366,"deaths":0,"injuries":301,"malfunctions":1064,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Leadless Pacemaker (product code PNJ), 2025 Q4: 1,239 adverse event reports received by the FDA (56 death, 440 injury, 743 malfunction and 0 other).","value":1239,"unit":"device adverse event reports received","reports":1239,"deaths":56,"injuries":440,"malfunctions":743,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QZI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2025 Q4: 1,206 adverse event reports received by the FDA (34 death, 559 injury, 612 malfunction and 1 other).","value":1206,"unit":"device adverse event reports received","reports":1206,"deaths":34,"injuries":559,"malfunctions":612,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2025 Q4: 1,191 adverse event reports received by the FDA (32 death, 214 injury, 945 malfunction and 0 other).","value":1191,"unit":"device adverse event reports received","reports":1191,"deaths":32,"injuries":214,"malfunctions":945,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2025 Q4: 1,187 adverse event reports received by the FDA (0 death, 11 injury, 1,176 malfunction and 0 other).","value":1187,"unit":"device adverse event reports received","reports":1187,"deaths":0,"injuries":11,"malfunctions":1176,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FOZ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2025 Q4: 1,172 adverse event reports received by the FDA (1 death, 72 injury, 1,099 malfunction and 0 other).","value":1172,"unit":"device adverse event reports received","reports":1172,"deaths":1,"injuries":72,"malfunctions":1099,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JJE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2025 Q4: 1,165 adverse event reports received by the FDA (0 death, 23 injury, 1,142 malfunction and 0 other).","value":1165,"unit":"device adverse event reports received","reports":1165,"deaths":0,"injuries":23,"malfunctions":1142,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2025 Q4: 1,152 adverse event reports received by the FDA (0 death, 84 injury, 1,068 malfunction and 0 other).","value":1152,"unit":"device adverse event reports received","reports":1152,"deaths":0,"injuries":84,"malfunctions":1068,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2025 Q4: 1,063 adverse event reports received by the FDA (23 death, 14 injury, 1,026 malfunction and 0 other).","value":1063,"unit":"device adverse event reports received","reports":1063,"deaths":23,"injuries":14,"malfunctions":1026,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2025 Q4: 1,052 adverse event reports received by the FDA (0 death, 41 injury, 1,011 malfunction and 0 other).","value":1052,"unit":"device adverse event reports received","reports":1052,"deaths":0,"injuries":41,"malfunctions":1011,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2025 Q4: 1,026 adverse event reports received by the FDA (0 death, 73 injury, 952 malfunction and 1 other).","value":1026,"unit":"device adverse event reports received","reports":1026,"deaths":0,"injuries":73,"malfunctions":952,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Syringe, Piston (product code FMF), 2025 Q4: 1,016 adverse event reports received by the FDA (2 death, 102 injury, 912 malfunction and 0 other).","value":1016,"unit":"device adverse event reports received","reports":1016,"deaths":2,"injuries":102,"malfunctions":912,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2025 Q4: 962 adverse event reports received by the FDA (0 death, 142 injury, 820 malfunction and 0 other).","value":962,"unit":"device adverse event reports received","reports":962,"deaths":0,"injuries":142,"malfunctions":820,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2025 Q4: 959 adverse event reports received by the FDA (0 death, 668 injury, 291 malfunction and 0 other).","value":959,"unit":"device adverse event reports received","reports":959,"deaths":0,"injuries":668,"malfunctions":291,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2025 Q4: 925 adverse event reports received by the FDA (1 death, 20 injury, 904 malfunction and 0 other).","value":925,"unit":"device adverse event reports received","reports":925,"deaths":1,"injuries":20,"malfunctions":904,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2025 Q4: 892 adverse event reports received by the FDA (0 death, 22 injury, 870 malfunction and 0 other).","value":892,"unit":"device adverse event reports received","reports":892,"deaths":0,"injuries":22,"malfunctions":870,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2025 Q4: 888 adverse event reports received by the FDA (42 death, 446 injury, 400 malfunction and 0 other).","value":888,"unit":"device adverse event reports received","reports":888,"deaths":42,"injuries":446,"malfunctions":400,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2025 Q4: 880 adverse event reports received by the FDA (0 death, 101 injury, 779 malfunction and 0 other).","value":880,"unit":"device adverse event reports received","reports":880,"deaths":0,"injuries":101,"malfunctions":779,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2025 Q4: 880 adverse event reports received by the FDA (0 death, 2 injury, 878 malfunction and 0 other).","value":880,"unit":"device adverse event reports received","reports":880,"deaths":0,"injuries":2,"malfunctions":878,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2025 Q4: 878 adverse event reports received by the FDA (2 death, 420 injury, 456 malfunction and 0 other).","value":878,"unit":"device adverse event reports received","reports":878,"deaths":2,"injuries":420,"malfunctions":456,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MIH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2025 Q4: 848 adverse event reports received by the FDA (44 death, 637 injury, 167 malfunction and 0 other).","value":848,"unit":"device adverse event reports received","reports":848,"deaths":44,"injuries":637,"malfunctions":167,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FKX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2025 Q4: 846 adverse event reports received by the FDA (15 death, 313 injury, 518 malfunction and 0 other).","value":846,"unit":"device adverse event reports received","reports":846,"deaths":15,"injuries":313,"malfunctions":518,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2025 Q4: 840 adverse event reports received by the FDA (0 death, 35 injury, 805 malfunction and 0 other).","value":840,"unit":"device adverse event reports received","reports":840,"deaths":0,"injuries":35,"malfunctions":805,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2025 Q4: 814 adverse event reports received by the FDA (14 death, 416 injury, 384 malfunction and 0 other).","value":814,"unit":"device adverse event reports received","reports":814,"deaths":14,"injuries":416,"malfunctions":384,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2025 Q4: 796 adverse event reports received by the FDA (0 death, 709 injury, 87 malfunction and 0 other).","value":796,"unit":"device adverse event reports received","reports":796,"deaths":0,"injuries":709,"malfunctions":87,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PHX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2025 Q4: 791 adverse event reports received by the FDA (0 death, 681 injury, 110 malfunction and 0 other).","value":791,"unit":"device adverse event reports received","reports":791,"deaths":0,"injuries":681,"malfunctions":110,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OLO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2025 Q4: 790 adverse event reports received by the FDA (1 death, 89 injury, 700 malfunction and 0 other).","value":790,"unit":"device adverse event reports received","reports":790,"deaths":1,"injuries":89,"malfunctions":700,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2025 Q4: 787 adverse event reports received by the FDA (2 death, 20 injury, 764 malfunction and 1 other).","value":787,"unit":"device adverse event reports received","reports":787,"deaths":2,"injuries":20,"malfunctions":764,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2025 Q4: 787 adverse event reports received by the FDA (0 death, 430 injury, 357 malfunction and 0 other).","value":787,"unit":"device adverse event reports received","reports":787,"deaths":0,"injuries":430,"malfunctions":357,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Steerable (product code DRA), 2025 Q4: 773 adverse event reports received by the FDA (8 death, 211 injury, 554 malfunction and 0 other).","value":773,"unit":"device adverse event reports received","reports":773,"deaths":8,"injuries":211,"malfunctions":554,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2025 Q4: 769 adverse event reports received by the FDA (9 death, 81 injury, 679 malfunction and 0 other).","value":769,"unit":"device adverse event reports received","reports":769,"deaths":9,"injuries":81,"malfunctions":679,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Template (product code HWT), 2025 Q4: 757 adverse event reports received by the FDA (0 death, 6 injury, 751 malfunction and 0 other).","value":757,"unit":"device adverse event reports received","reports":757,"deaths":0,"injuries":6,"malfunctions":751,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2025 Q4: 753 adverse event reports received by the FDA (6 death, 477 injury, 270 malfunction and 0 other).","value":753,"unit":"device adverse event reports received","reports":753,"deaths":6,"injuries":477,"malfunctions":270,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2025 Q4: 729 adverse event reports received by the FDA (0 death, 35 injury, 694 malfunction and 0 other).","value":729,"unit":"device adverse event reports received","reports":729,"deaths":0,"injuries":35,"malfunctions":694,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2025 Q4: 722 adverse event reports received by the FDA (2 death, 12 injury, 708 malfunction and 0 other).","value":722,"unit":"device adverse event reports received","reports":722,"deaths":2,"injuries":12,"malfunctions":708,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Percutaneous (product code DQY), 2025 Q4: 719 adverse event reports received by the FDA (14 death, 209 injury, 496 malfunction and 0 other).","value":719,"unit":"device adverse event reports received","reports":719,"deaths":14,"injuries":209,"malfunctions":496,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2025 Q4: 713 adverse event reports received by the FDA (1 death, 158 injury, 553 malfunction and 1 other).","value":713,"unit":"device adverse event reports received","reports":713,"deaths":1,"injuries":158,"malfunctions":553,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2025 Q4: 699 adverse event reports received by the FDA (0 death, 691 injury, 8 malfunction and 0 other).","value":699,"unit":"device adverse event reports received","reports":699,"deaths":0,"injuries":691,"malfunctions":8,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IZI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2025 Q4: 690 adverse event reports received by the FDA (1 death, 8 injury, 681 malfunction and 0 other).","value":690,"unit":"device adverse event reports received","reports":690,"deaths":1,"injuries":8,"malfunctions":681,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NEW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2025 Q4: 655 adverse event reports received by the FDA (0 death, 118 injury, 537 malfunction and 0 other).","value":655,"unit":"device adverse event reports received","reports":655,"deaths":0,"injuries":118,"malfunctions":537,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2025 Q4: 654 adverse event reports received by the FDA (4 death, 596 injury, 54 malfunction and 0 other).","value":654,"unit":"device adverse event reports received","reports":654,"deaths":4,"injuries":596,"malfunctions":54,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2025 Q4: 628 adverse event reports received by the FDA (1 death, 485 injury, 142 malfunction and 0 other).","value":628,"unit":"device adverse event reports received","reports":628,"deaths":1,"injuries":485,"malfunctions":142,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PSV:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2025 Q4: 620 adverse event reports received by the FDA (0 death, 18 injury, 602 malfunction and 0 other).","value":620,"unit":"device adverse event reports received","reports":620,"deaths":0,"injuries":18,"malfunctions":602,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2025 Q4: 617 adverse event reports received by the FDA (0 death, 4 injury, 613 malfunction and 0 other).","value":617,"unit":"device adverse event reports received","reports":617,"deaths":0,"injuries":4,"malfunctions":613,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FHW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2025 Q4: 616 adverse event reports received by the FDA (0 death, 564 injury, 52 malfunction and 0 other).","value":616,"unit":"device adverse event reports received","reports":616,"deaths":0,"injuries":564,"malfunctions":52,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2025 Q4: 614 adverse event reports received by the FDA (0 death, 59 injury, 555 malfunction and 0 other).","value":614,"unit":"device adverse event reports received","reports":614,"deaths":0,"injuries":59,"malfunctions":555,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIQ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2025 Q4: 603 adverse event reports received by the FDA (36 death, 277 injury, 289 malfunction and 1 other).","value":603,"unit":"device adverse event reports received","reports":603,"deaths":36,"injuries":277,"malfunctions":289,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2025 Q4: 595 adverse event reports received by the FDA (0 death, 7 injury, 588 malfunction and 0 other).","value":595,"unit":"device adverse event reports received","reports":595,"deaths":0,"injuries":7,"malfunctions":588,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NGV:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2025 Q4: 594 adverse event reports received by the FDA (65 death, 491 injury, 38 malfunction and 0 other).","value":594,"unit":"device adverse event reports received","reports":594,"deaths":65,"injuries":491,"malfunctions":38,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NQO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NQO","deviceName":"Prosthesis, Spinous Process Spacer/Plate","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Spinous Process Spacer/Plate (product code NQO), 2025 Q4: 593 adverse event reports received by the FDA (0 death, 4 injury, 589 malfunction and 0 other).","value":593,"unit":"device adverse event reports received","reports":593,"deaths":0,"injuries":4,"malfunctions":589,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2025 Q4: 572 adverse event reports received by the FDA (13 death, 193 injury, 366 malfunction and 0 other).","value":572,"unit":"device adverse event reports received","reports":572,"deaths":13,"injuries":193,"malfunctions":366,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LIT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2025 Q4: 565 adverse event reports received by the FDA (1 death, 42 injury, 522 malfunction and 0 other).","value":565,"unit":"device adverse event reports received","reports":565,"deaths":1,"injuries":42,"malfunctions":522,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2025 Q4: 562 adverse event reports received by the FDA (0 death, 518 injury, 44 malfunction and 0 other).","value":562,"unit":"device adverse event reports received","reports":562,"deaths":0,"injuries":518,"malfunctions":44,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2025 Q4: 560 adverse event reports received by the FDA (1 death, 43 injury, 516 malfunction and 0 other).","value":560,"unit":"device adverse event reports received","reports":560,"deaths":1,"injuries":43,"malfunctions":516,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Impactor (product code HWA), 2025 Q4: 559 adverse event reports received by the FDA (0 death, 3 injury, 556 malfunction and 0 other).","value":559,"unit":"device adverse event reports received","reports":559,"deaths":0,"injuries":3,"malfunctions":556,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LMH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2025 Q4: 547 adverse event reports received by the FDA (0 death, 546 injury, 1 malfunction and 0 other).","value":547,"unit":"device adverse event reports received","reports":547,"deaths":0,"injuries":546,"malfunctions":1,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Arthroscope (product code HRX), 2025 Q4: 543 adverse event reports received by the FDA (0 death, 20 injury, 523 malfunction and 0 other).","value":543,"unit":"device adverse event reports received","reports":543,"deaths":0,"injuries":20,"malfunctions":523,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2025 Q4: 536 adverse event reports received by the FDA (1 death, 9 injury, 526 malfunction and 0 other).","value":536,"unit":"device adverse event reports received","reports":536,"deaths":1,"injuries":9,"malfunctions":526,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2025 Q4: 532 adverse event reports received by the FDA (6 death, 252 injury, 274 malfunction and 0 other).","value":532,"unit":"device adverse event reports received","reports":532,"deaths":6,"injuries":252,"malfunctions":274,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2025 Q4: 529 adverse event reports received by the FDA (0 death, 516 injury, 13 malfunction and 0 other).","value":529,"unit":"device adverse event reports received","reports":529,"deaths":0,"injuries":516,"malfunctions":13,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2025 Q4: 518 adverse event reports received by the FDA (0 death, 112 injury, 406 malfunction and 0 other).","value":518,"unit":"device adverse event reports received","reports":518,"deaths":0,"injuries":112,"malfunctions":406,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2025 Q4: 514 adverse event reports received by the FDA (0 death, 9 injury, 505 malfunction and 0 other).","value":514,"unit":"device adverse event reports received","reports":514,"deaths":0,"injuries":9,"malfunctions":505,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Clip, Implantable (product code FZP), 2025 Q4: 508 adverse event reports received by the FDA (0 death, 10 injury, 498 malfunction and 0 other).","value":508,"unit":"device adverse event reports received","reports":508,"deaths":0,"injuries":10,"malfunctions":498,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2025 Q4: 508 adverse event reports received by the FDA (2 death, 39 injury, 467 malfunction and 0 other).","value":508,"unit":"device adverse event reports received","reports":508,"deaths":2,"injuries":39,"malfunctions":467,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2025 Q4: 507 adverse event reports received by the FDA (1 death, 70 injury, 435 malfunction and 1 other).","value":507,"unit":"device adverse event reports received","reports":507,"deaths":1,"injuries":70,"malfunctions":435,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2025 Q4: 501 adverse event reports received by the FDA (15 death, 436 injury, 50 malfunction and 0 other).","value":501,"unit":"device adverse event reports received","reports":501,"deaths":15,"injuries":436,"malfunctions":50,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MZF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Test, Hiv Detection (product code MZF), 2025 Q4: 499 adverse event reports received by the FDA (0 death, 2 injury, 497 malfunction and 0 other).","value":499,"unit":"device adverse event reports received","reports":499,"deaths":0,"injuries":2,"malfunctions":497,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HXX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Screwdriver (product code HXX), 2025 Q4: 490 adverse event reports received by the FDA (0 death, 11 injury, 479 malfunction and 0 other).","value":490,"unit":"device adverse event reports received","reports":490,"deaths":0,"injuries":11,"malfunctions":479,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Instrument, Biopsy (product code KNW), 2025 Q4: 490 adverse event reports received by the FDA (0 death, 74 injury, 413 malfunction and 3 other).","value":490,"unit":"device adverse event reports received","reports":490,"deaths":0,"injuries":74,"malfunctions":413,"other":3,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Thermal Regulating (product code DWJ), 2025 Q4: 487 adverse event reports received by the FDA (0 death, 3 injury, 484 malfunction and 0 other).","value":487,"unit":"device adverse event reports received","reports":487,"deaths":0,"injuries":3,"malfunctions":484,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2025 Q4: 484 adverse event reports received by the FDA (1 death, 58 injury, 425 malfunction and 0 other).","value":484,"unit":"device adverse event reports received","reports":484,"deaths":1,"injuries":58,"malfunctions":425,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MOM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2025 Q4: 483 adverse event reports received by the FDA (4 death, 164 injury, 315 malfunction and 0 other).","value":483,"unit":"device adverse event reports received","reports":483,"deaths":4,"injuries":164,"malfunctions":315,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2025 Q4: 481 adverse event reports received by the FDA (0 death, 4 injury, 477 malfunction and 0 other).","value":481,"unit":"device adverse event reports received","reports":481,"deaths":0,"injuries":4,"malfunctions":477,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Replacement Heart-Valve (product code DYE), 2025 Q4: 479 adverse event reports received by the FDA (7 death, 440 injury, 32 malfunction and 0 other).","value":479,"unit":"device adverse event reports received","reports":479,"deaths":7,"injuries":440,"malfunctions":32,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LHI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2025 Q4: 475 adverse event reports received by the FDA (0 death, 1 injury, 473 malfunction and 1 other).","value":475,"unit":"device adverse event reports received","reports":475,"deaths":0,"injuries":1,"malfunctions":473,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FJK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2025 Q4: 474 adverse event reports received by the FDA (1 death, 3 injury, 470 malfunction and 0 other).","value":474,"unit":"device adverse event reports received","reports":474,"deaths":1,"injuries":3,"malfunctions":470,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2025 Q4: 473 adverse event reports received by the FDA (4 death, 55 injury, 414 malfunction and 0 other).","value":473,"unit":"device adverse event reports received","reports":473,"deaths":4,"injuries":55,"malfunctions":414,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2025 Q4: 464 adverse event reports received by the FDA (4 death, 44 injury, 416 malfunction and 0 other).","value":464,"unit":"device adverse event reports received","reports":464,"deaths":4,"injuries":44,"malfunctions":416,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2025 Q4: 461 adverse event reports received by the FDA (1 death, 339 injury, 121 malfunction and 0 other).","value":461,"unit":"device adverse event reports received","reports":461,"deaths":1,"injuries":339,"malfunctions":121,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2025 Q4: 456 adverse event reports received by the FDA (45 death, 2 injury, 409 malfunction and 0 other).","value":456,"unit":"device adverse event reports received","reports":456,"deaths":45,"injuries":2,"malfunctions":409,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PMP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2025 Q4: 452 adverse event reports received by the FDA (0 death, 444 injury, 8 malfunction and 0 other).","value":452,"unit":"device adverse event reports received","reports":452,"deaths":0,"injuries":444,"malfunctions":8,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QCB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2025 Q4: 443 adverse event reports received by the FDA (0 death, 443 injury, 0 malfunction and 0 other).","value":443,"unit":"device adverse event reports received","reports":443,"deaths":0,"injuries":443,"malfunctions":0,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2025 Q4: 434 adverse event reports received by the FDA (0 death, 192 injury, 242 malfunction and 0 other).","value":434,"unit":"device adverse event reports received","reports":434,"deaths":0,"injuries":192,"malfunctions":242,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2025 Q4: 429 adverse event reports received by the FDA (0 death, 0 injury, 429 malfunction and 0 other).","value":429,"unit":"device adverse event reports received","reports":429,"deaths":0,"injuries":0,"malfunctions":429,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2025 Q4: 426 adverse event reports received by the FDA (6 death, 155 injury, 265 malfunction and 0 other).","value":426,"unit":"device adverse event reports received","reports":426,"deaths":6,"injuries":155,"malfunctions":265,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LOX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2025 Q4: 416 adverse event reports received by the FDA (0 death, 54 injury, 362 malfunction and 0 other).","value":416,"unit":"device adverse event reports received","reports":416,"deaths":0,"injuries":54,"malfunctions":362,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OUT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2025 Q4: 415 adverse event reports received by the FDA (7 death, 71 injury, 337 malfunction and 0 other).","value":415,"unit":"device adverse event reports received","reports":415,"deaths":7,"injuries":71,"malfunctions":337,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NXC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Aligner, Sequential (product code NXC), 2025 Q4: 414 adverse event reports received by the FDA (0 death, 409 injury, 5 malfunction and 0 other).","value":414,"unit":"device adverse event reports received","reports":414,"deaths":0,"injuries":409,"malfunctions":5,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JCW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2025 Q4: 402 adverse event reports received by the FDA (0 death, 392 injury, 10 malfunction and 0 other).","value":402,"unit":"device adverse event reports received","reports":402,"deaths":0,"injuries":392,"malfunctions":10,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JDI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2025 Q4: 396 adverse event reports received by the FDA (0 death, 375 injury, 21 malfunction and 0 other).","value":396,"unit":"device adverse event reports received","reports":396,"deaths":0,"injuries":375,"malfunctions":21,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NZU:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2025 Q4: 389 adverse event reports received by the FDA (0 death, 147 injury, 242 malfunction and 0 other).","value":389,"unit":"device adverse event reports received","reports":389,"deaths":0,"injuries":147,"malfunctions":242,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2025 Q4: 388 adverse event reports received by the FDA (1 death, 186 injury, 201 malfunction and 0 other).","value":388,"unit":"device adverse event reports received","reports":388,"deaths":1,"injuries":186,"malfunctions":201,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2025 Q4: 386 adverse event reports received by the FDA (0 death, 9 injury, 377 malfunction and 0 other).","value":386,"unit":"device adverse event reports received","reports":386,"deaths":0,"injuries":9,"malfunctions":377,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Driver, Prosthesis (product code HWR), 2025 Q4: 382 adverse event reports received by the FDA (0 death, 3 injury, 379 malfunction and 0 other).","value":382,"unit":"device adverse event reports received","reports":382,"deaths":0,"injuries":3,"malfunctions":379,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Bit, Drill (product code HTW), 2025 Q4: 375 adverse event reports received by the FDA (0 death, 27 injury, 348 malfunction and 0 other).","value":375,"unit":"device adverse event reports received","reports":375,"deaths":0,"injuries":27,"malfunctions":348,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SBA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2025 Q4: 373 adverse event reports received by the FDA (0 death, 107 injury, 266 malfunction and 0 other).","value":373,"unit":"device adverse event reports received","reports":373,"deaths":0,"injuries":107,"malfunctions":266,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2025 Q4: 371 adverse event reports received by the FDA (6 death, 67 injury, 298 malfunction and 0 other).","value":371,"unit":"device adverse event reports received","reports":371,"deaths":6,"injuries":67,"malfunctions":298,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LYJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2025 Q4: 363 adverse event reports received by the FDA (20 death, 135 injury, 208 malfunction and 0 other).","value":363,"unit":"device adverse event reports received","reports":363,"deaths":20,"injuries":135,"malfunctions":208,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2025 Q4: 361 adverse event reports received by the FDA (0 death, 6 injury, 355 malfunction and 0 other).","value":361,"unit":"device adverse event reports received","reports":361,"deaths":0,"injuries":6,"malfunctions":355,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Coude (product code EZC), 2025 Q4: 358 adverse event reports received by the FDA (0 death, 24 injury, 334 malfunction and 0 other).","value":358,"unit":"device adverse event reports received","reports":358,"deaths":0,"injuries":24,"malfunctions":334,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MFK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2025 Q4: 351 adverse event reports received by the FDA (0 death, 220 injury, 131 malfunction and 0 other).","value":351,"unit":"device adverse event reports received","reports":351,"deaths":0,"injuries":220,"malfunctions":131,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTZ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2025 Q4: 350 adverse event reports received by the FDA (10 death, 28 injury, 312 malfunction and 0 other).","value":350,"unit":"device adverse event reports received","reports":350,"deaths":10,"injuries":28,"malfunctions":312,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Plate, Bone (product code JEY), 2025 Q4: 350 adverse event reports received by the FDA (0 death, 50 injury, 300 malfunction and 0 other).","value":350,"unit":"device adverse event reports received","reports":350,"deaths":0,"injuries":50,"malfunctions":300,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2025 Q4: 349 adverse event reports received by the FDA (0 death, 155 injury, 194 malfunction and 0 other).","value":349,"unit":"device adverse event reports received","reports":349,"deaths":0,"injuries":155,"malfunctions":194,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2025 Q4: 347 adverse event reports received by the FDA (2 death, 243 injury, 102 malfunction and 0 other).","value":347,"unit":"device adverse event reports received","reports":347,"deaths":2,"injuries":243,"malfunctions":102,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2025 Q4: 335 adverse event reports received by the FDA (0 death, 42 injury, 293 malfunction and 0 other).","value":335,"unit":"device adverse event reports received","reports":335,"deaths":0,"injuries":42,"malfunctions":293,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ERL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2025 Q4: 334 adverse event reports received by the FDA (0 death, 1 injury, 333 malfunction and 0 other).","value":334,"unit":"device adverse event reports received","reports":334,"deaths":0,"injuries":1,"malfunctions":333,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Wheelchair, Powered (product code ITI), 2025 Q4: 333 adverse event reports received by the FDA (1 death, 28 injury, 304 malfunction and 0 other).","value":333,"unit":"device adverse event reports received","reports":333,"deaths":1,"injuries":28,"malfunctions":304,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2025 Q4: 331 adverse event reports received by the FDA (0 death, 2 injury, 329 malfunction and 0 other).","value":331,"unit":"device adverse event reports received","reports":331,"deaths":0,"injuries":2,"malfunctions":329,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JXG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2025 Q4: 330 adverse event reports received by the FDA (3 death, 197 injury, 130 malfunction and 0 other).","value":330,"unit":"device adverse event reports received","reports":330,"deaths":3,"injuries":197,"malfunctions":130,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SAF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2025 Q4: 320 adverse event reports received by the FDA (0 death, 27 injury, 293 malfunction and 0 other).","value":320,"unit":"device adverse event reports received","reports":320,"deaths":0,"injuries":27,"malfunctions":293,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2025 Q4: 319 adverse event reports received by the FDA (0 death, 42 injury, 277 malfunction and 0 other).","value":319,"unit":"device adverse event reports received","reports":319,"deaths":0,"injuries":42,"malfunctions":277,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NOU:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2025 Q4: 305 adverse event reports received by the FDA (9 death, 11 injury, 285 malfunction and 0 other).","value":305,"unit":"device adverse event reports received","reports":305,"deaths":9,"injuries":11,"malfunctions":285,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OAE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2025 Q4: 302 adverse event reports received by the FDA (9 death, 148 injury, 145 malfunction and 0 other).","value":302,"unit":"device adverse event reports received","reports":302,"deaths":9,"injuries":148,"malfunctions":145,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stapler, Surgical (product code GAG), 2025 Q4: 299 adverse event reports received by the FDA (5 death, 51 injury, 243 malfunction and 0 other).","value":299,"unit":"device adverse event reports received","reports":299,"deaths":5,"injuries":51,"malfunctions":243,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2025 Q4: 297 adverse event reports received by the FDA (0 death, 286 injury, 11 malfunction and 0 other).","value":297,"unit":"device adverse event reports received","reports":297,"deaths":0,"injuries":286,"malfunctions":11,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2025 Q4: 296 adverse event reports received by the FDA (0 death, 15 injury, 281 malfunction and 0 other).","value":296,"unit":"device adverse event reports received","reports":296,"deaths":0,"injuries":15,"malfunctions":281,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OBJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2025 Q4: 290 adverse event reports received by the FDA (2 death, 31 injury, 257 malfunction and 0 other).","value":290,"unit":"device adverse event reports received","reports":290,"deaths":2,"injuries":31,"malfunctions":257,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GWF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2025 Q4: 285 adverse event reports received by the FDA (0 death, 6 injury, 279 malfunction and 0 other).","value":285,"unit":"device adverse event reports received","reports":285,"deaths":0,"injuries":6,"malfunctions":279,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTQ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2025 Q4: 281 adverse event reports received by the FDA (0 death, 4 injury, 277 malfunction and 0 other).","value":281,"unit":"device adverse event reports received","reports":281,"deaths":0,"injuries":4,"malfunctions":277,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2025 Q4: 277 adverse event reports received by the FDA (0 death, 275 injury, 2 malfunction and 0 other).","value":277,"unit":"device adverse event reports received","reports":277,"deaths":0,"injuries":275,"malfunctions":2,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2025 Q4: 273 adverse event reports received by the FDA (0 death, 12 injury, 261 malfunction and 0 other).","value":273,"unit":"device adverse event reports received","reports":273,"deaths":0,"injuries":12,"malfunctions":261,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2025 Q4: 273 adverse event reports received by the FDA (11 death, 122 injury, 140 malfunction and 0 other).","value":273,"unit":"device adverse event reports received","reports":273,"deaths":11,"injuries":122,"malfunctions":140,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2025 Q4: 273 adverse event reports received by the FDA (0 death, 19 injury, 254 malfunction and 0 other).","value":273,"unit":"device adverse event reports received","reports":273,"deaths":0,"injuries":19,"malfunctions":254,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2025 Q4: 272 adverse event reports received by the FDA (18 death, 90 injury, 164 malfunction and 0 other).","value":272,"unit":"device adverse event reports received","reports":272,"deaths":18,"injuries":90,"malfunctions":164,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2025 Q4: 266 adverse event reports received by the FDA (13 death, 124 injury, 129 malfunction and 0 other).","value":266,"unit":"device adverse event reports received","reports":266,"deaths":13,"injuries":124,"malfunctions":129,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2025 Q4: 265 adverse event reports received by the FDA (0 death, 22 injury, 243 malfunction and 0 other).","value":265,"unit":"device adverse event reports received","reports":265,"deaths":0,"injuries":22,"malfunctions":243,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2025 Q4: 264 adverse event reports received by the FDA (3 death, 11 injury, 250 malfunction and 0 other).","value":264,"unit":"device adverse event reports received","reports":264,"deaths":3,"injuries":11,"malfunctions":250,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NSA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2025 Q4: 263 adverse event reports received by the FDA (3 death, 2 injury, 258 malfunction and 0 other).","value":263,"unit":"device adverse event reports received","reports":263,"deaths":3,"injuries":2,"malfunctions":258,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MND:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ligator, Esophageal (product code MND), 2025 Q4: 262 adverse event reports received by the FDA (0 death, 20 injury, 242 malfunction and 0 other).","value":262,"unit":"device adverse event reports received","reports":262,"deaths":0,"injuries":20,"malfunctions":242,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Device, Anti-Snoring (product code LRK), 2025 Q4: 260 adverse event reports received by the FDA (0 death, 30 injury, 230 malfunction and 0 other).","value":260,"unit":"device adverse event reports received","reports":260,"deaths":0,"injuries":30,"malfunctions":230,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2025 Q4: 258 adverse event reports received by the FDA (2 death, 91 injury, 165 malfunction and 0 other).","value":258,"unit":"device adverse event reports received","reports":258,"deaths":2,"injuries":91,"malfunctions":165,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2025 Q4: 258 adverse event reports received by the FDA (8 death, 23 injury, 227 malfunction and 0 other).","value":258,"unit":"device adverse event reports received","reports":258,"deaths":8,"injuries":23,"malfunctions":227,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNQ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2025 Q4: 255 adverse event reports received by the FDA (0 death, 249 injury, 6 malfunction and 0 other).","value":255,"unit":"device adverse event reports received","reports":255,"deaths":0,"injuries":249,"malfunctions":6,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NHA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2025 Q4: 249 adverse event reports received by the FDA (0 death, 89 injury, 160 malfunction and 0 other).","value":249,"unit":"device adverse event reports received","reports":249,"deaths":0,"injuries":89,"malfunctions":160,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GBX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Irrigation (product code GBX), 2025 Q4: 247 adverse event reports received by the FDA (2 death, 32 injury, 213 malfunction and 0 other).","value":247,"unit":"device adverse event reports received","reports":247,"deaths":2,"injuries":32,"malfunctions":213,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2025 Q4: 247 adverse event reports received by the FDA (0 death, 9 injury, 238 malfunction and 0 other).","value":247,"unit":"device adverse event reports received","reports":247,"deaths":0,"injuries":9,"malfunctions":238,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KOD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Urological (product code KOD), 2025 Q4: 242 adverse event reports received by the FDA (0 death, 36 injury, 206 malfunction and 0 other).","value":242,"unit":"device adverse event reports received","reports":242,"deaths":0,"injuries":36,"malfunctions":206,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MMI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2025 Q4: 238 adverse event reports received by the FDA (0 death, 15 injury, 223 malfunction and 0 other).","value":238,"unit":"device adverse event reports received","reports":238,"deaths":0,"injuries":15,"malfunctions":223,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PFO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2025 Q4: 238 adverse event reports received by the FDA (0 death, 216 injury, 22 malfunction and 0 other).","value":238,"unit":"device adverse event reports received","reports":238,"deaths":0,"injuries":216,"malfunctions":22,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Programmer, Pacemaker (product code KRG), 2025 Q4: 237 adverse event reports received by the FDA (0 death, 3 injury, 234 malfunction and 0 other).","value":237,"unit":"device adverse event reports received","reports":237,"deaths":0,"injuries":3,"malfunctions":234,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2025 Q4: 236 adverse event reports received by the FDA (0 death, 211 injury, 25 malfunction and 0 other).","value":236,"unit":"device adverse event reports received","reports":236,"deaths":0,"injuries":211,"malfunctions":25,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2025 Q4: 234 adverse event reports received by the FDA (4 death, 4 injury, 226 malfunction and 0 other).","value":234,"unit":"device adverse event reports received","reports":234,"deaths":4,"injuries":4,"malfunctions":226,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2025 Q4: 230 adverse event reports received by the FDA (4 death, 22 injury, 204 malfunction and 0 other).","value":230,"unit":"device adverse event reports received","reports":230,"deaths":4,"injuries":22,"malfunctions":204,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2025 Q4: 219 adverse event reports received by the FDA (0 death, 2 injury, 217 malfunction and 0 other).","value":219,"unit":"device adverse event reports received","reports":219,"deaths":0,"injuries":2,"malfunctions":217,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Endoscope, Rigid (product code GCM), 2025 Q4: 213 adverse event reports received by the FDA (0 death, 0 injury, 213 malfunction and 0 other).","value":213,"unit":"device adverse event reports received","reports":213,"deaths":0,"injuries":0,"malfunctions":213,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JOH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2025 Q4: 212 adverse event reports received by the FDA (2 death, 17 injury, 193 malfunction and 0 other).","value":212,"unit":"device adverse event reports received","reports":212,"deaths":2,"injuries":17,"malfunctions":193,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2025 Q4: 211 adverse event reports received by the FDA (0 death, 211 injury, 0 malfunction and 0 other).","value":211,"unit":"device adverse event reports received","reports":211,"deaths":0,"injuries":211,"malfunctions":0,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2025 Q4: 208 adverse event reports received by the FDA (0 death, 9 injury, 199 malfunction and 0 other).","value":208,"unit":"device adverse event reports received","reports":208,"deaths":0,"injuries":9,"malfunctions":199,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2025 Q4: 206 adverse event reports received by the FDA (1 death, 2 injury, 203 malfunction and 0 other).","value":206,"unit":"device adverse event reports received","reports":206,"deaths":1,"injuries":2,"malfunctions":203,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2025 Q4: 203 adverse event reports received by the FDA (0 death, 32 injury, 171 malfunction and 0 other).","value":203,"unit":"device adverse event reports received","reports":203,"deaths":0,"injuries":32,"malfunctions":171,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stretcher, Wheeled (product code FPO), 2025 Q4: 201 adverse event reports received by the FDA (2 death, 4 injury, 195 malfunction and 0 other).","value":201,"unit":"device adverse event reports received","reports":201,"deaths":2,"injuries":4,"malfunctions":195,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Septostomy (product code DXF), 2025 Q4: 196 adverse event reports received by the FDA (9 death, 124 injury, 63 malfunction and 0 other).","value":196,"unit":"device adverse event reports received","reports":196,"deaths":9,"injuries":124,"malfunctions":63,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MTA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2025 Q4: 196 adverse event reports received by the FDA (0 death, 196 injury, 0 malfunction and 0 other).","value":196,"unit":"device adverse event reports received","reports":196,"deaths":0,"injuries":196,"malfunctions":0,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2025 Q4: 195 adverse event reports received by the FDA (23 death, 85 injury, 87 malfunction and 0 other).","value":195,"unit":"device adverse event reports received","reports":195,"deaths":23,"injuries":85,"malfunctions":87,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2025 Q4: 194 adverse event reports received by the FDA (0 death, 182 injury, 12 malfunction and 0 other).","value":194,"unit":"device adverse event reports received","reports":194,"deaths":0,"injuries":182,"malfunctions":12,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2025 Q4: 192 adverse event reports received by the FDA (0 death, 52 injury, 140 malfunction and 0 other).","value":192,"unit":"device adverse event reports received","reports":192,"deaths":0,"injuries":52,"malfunctions":140,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2025 Q4: 190 adverse event reports received by the FDA (1 death, 59 injury, 130 malfunction and 0 other).","value":190,"unit":"device adverse event reports received","reports":190,"deaths":1,"injuries":59,"malfunctions":130,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2025 Q4: 189 adverse event reports received by the FDA (0 death, 6 injury, 183 malfunction and 0 other).","value":189,"unit":"device adverse event reports received","reports":189,"deaths":0,"injuries":6,"malfunctions":183,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MLV:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2025 Q4: 187 adverse event reports received by the FDA (6 death, 65 injury, 116 malfunction and 0 other).","value":187,"unit":"device adverse event reports received","reports":187,"deaths":6,"injuries":65,"malfunctions":116,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2025 Q4: 186 adverse event reports received by the FDA (0 death, 152 injury, 34 malfunction and 0 other).","value":186,"unit":"device adverse event reports received","reports":186,"deaths":0,"injuries":152,"malfunctions":34,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HNN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Knife, Ophthalmic (product code HNN), 2025 Q4: 185 adverse event reports received by the FDA (0 death, 6 injury, 179 malfunction and 0 other).","value":185,"unit":"device adverse event reports received","reports":185,"deaths":0,"injuries":6,"malfunctions":179,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2025 Q4: 179 adverse event reports received by the FDA (0 death, 3 injury, 176 malfunction and 0 other).","value":179,"unit":"device adverse event reports received","reports":179,"deaths":0,"injuries":3,"malfunctions":176,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GFD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Dermatome (product code GFD), 2025 Q4: 178 adverse event reports received by the FDA (0 death, 13 injury, 165 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":0,"injuries":13,"malfunctions":165,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Calculator, Drug Dose (product code NDC), 2025 Q4: 178 adverse event reports received by the FDA (0 death, 0 injury, 178 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":0,"injuries":0,"malfunctions":178,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HCG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2025 Q4: 177 adverse event reports received by the FDA (5 death, 44 injury, 128 malfunction and 0 other).","value":177,"unit":"device adverse event reports received","reports":177,"deaths":5,"injuries":44,"malfunctions":128,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2025 Q4: 175 adverse event reports received by the FDA (3 death, 19 injury, 153 malfunction and 0 other).","value":175,"unit":"device adverse event reports received","reports":175,"deaths":3,"injuries":19,"malfunctions":153,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2025 Q4: 175 adverse event reports received by the FDA (0 death, 0 injury, 175 malfunction and 0 other).","value":175,"unit":"device adverse event reports received","reports":175,"deaths":0,"injuries":0,"malfunctions":175,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ETN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Nerve (product code ETN), 2025 Q4: 173 adverse event reports received by the FDA (0 death, 13 injury, 160 malfunction and 0 other).","value":173,"unit":"device adverse event reports received","reports":173,"deaths":0,"injuries":13,"malfunctions":160,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2025 Q4: 171 adverse event reports received by the FDA (2 death, 13 injury, 156 malfunction and 0 other).","value":171,"unit":"device adverse event reports received","reports":171,"deaths":2,"injuries":13,"malfunctions":156,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2025 Q4: 170 adverse event reports received by the FDA (4 death, 26 injury, 140 malfunction and 0 other).","value":170,"unit":"device adverse event reports received","reports":170,"deaths":4,"injuries":26,"malfunctions":140,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2025 Q4: 168 adverse event reports received by the FDA (10 death, 58 injury, 100 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":10,"injuries":58,"malfunctions":100,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stent, Iliac (product code NIO), 2025 Q4: 168 adverse event reports received by the FDA (2 death, 64 injury, 102 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":2,"injuries":64,"malfunctions":102,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2025 Q4: 164 adverse event reports received by the FDA (0 death, 19 injury, 145 malfunction and 0 other).","value":164,"unit":"device adverse event reports received","reports":164,"deaths":0,"injuries":19,"malfunctions":145,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2025 Q4: 163 adverse event reports received by the FDA (3 death, 18 injury, 141 malfunction and 1 other).","value":163,"unit":"device adverse event reports received","reports":163,"deaths":3,"injuries":18,"malfunctions":141,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2025 Q4: 163 adverse event reports received by the FDA (0 death, 35 injury, 128 malfunction and 0 other).","value":163,"unit":"device adverse event reports received","reports":163,"deaths":0,"injuries":35,"malfunctions":128,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LNH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2025 Q4: 160 adverse event reports received by the FDA (0 death, 42 injury, 118 malfunction and 0 other).","value":160,"unit":"device adverse event reports received","reports":160,"deaths":0,"injuries":42,"malfunctions":118,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAD:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stent, Ureteral (product code FAD), 2025 Q4: 158 adverse event reports received by the FDA (0 death, 40 injury, 118 malfunction and 0 other).","value":158,"unit":"device adverse event reports received","reports":158,"deaths":0,"injuries":40,"malfunctions":118,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FCG:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Biopsy Needle (product code FCG), 2025 Q4: 153 adverse event reports received by the FDA (0 death, 18 injury, 135 malfunction and 0 other).","value":153,"unit":"device adverse event reports received","reports":153,"deaths":0,"injuries":18,"malfunctions":135,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2025 Q4: 148 adverse event reports received by the FDA (0 death, 34 injury, 114 malfunction and 0 other).","value":148,"unit":"device adverse event reports received","reports":148,"deaths":0,"injuries":34,"malfunctions":114,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Reamer (product code HTO), 2025 Q4: 147 adverse event reports received by the FDA (0 death, 7 injury, 140 malfunction and 0 other).","value":147,"unit":"device adverse event reports received","reports":147,"deaths":0,"injuries":7,"malfunctions":140,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SFI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SFI","deviceName":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System (product code SFI), 2025 Q4: 142 adverse event reports received by the FDA (0 death, 1 injury, 141 malfunction and 0 other).","value":142,"unit":"device adverse event reports received","reports":142,"deaths":0,"injuries":1,"malfunctions":141,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PYX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2025 Q4: 140 adverse event reports received by the FDA (47 death, 54 injury, 39 malfunction and 0 other).","value":140,"unit":"device adverse event reports received","reports":140,"deaths":47,"injuries":54,"malfunctions":39,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2025 Q4: 139 adverse event reports received by the FDA (1 death, 4 injury, 134 malfunction and 0 other).","value":139,"unit":"device adverse event reports received","reports":139,"deaths":1,"injuries":4,"malfunctions":134,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FQH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Lavage, Jet (product code FQH), 2025 Q4: 138 adverse event reports received by the FDA (0 death, 5 injury, 133 malfunction and 0 other).","value":138,"unit":"device adverse event reports received","reports":138,"deaths":0,"injuries":5,"malfunctions":133,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GIM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2025 Q4: 137 adverse event reports received by the FDA (0 death, 0 injury, 137 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":0,"malfunctions":137,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HHS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2025 Q4: 137 adverse event reports received by the FDA (0 death, 136 injury, 0 malfunction and 1 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":136,"malfunctions":0,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2025 Q4: 137 adverse event reports received by the FDA (0 death, 1 injury, 136 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":1,"malfunctions":136,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Oximeter (product code DQA), 2025 Q4: 135 adverse event reports received by the FDA (1 death, 5 injury, 129 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":1,"injuries":5,"malfunctions":129,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LCJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2025 Q4: 135 adverse event reports received by the FDA (0 death, 106 injury, 29 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":0,"injuries":106,"malfunctions":29,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2025 Q4: 135 adverse event reports received by the FDA (0 death, 8 injury, 127 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":0,"injuries":8,"malfunctions":127,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QHJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2025 Q4: 134 adverse event reports received by the FDA (0 death, 52 injury, 82 malfunction and 0 other).","value":134,"unit":"device adverse event reports received","reports":134,"deaths":0,"injuries":52,"malfunctions":82,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2025 Q4: 133 adverse event reports received by the FDA (0 death, 0 injury, 133 malfunction and 0 other).","value":133,"unit":"device adverse event reports received","reports":133,"deaths":0,"injuries":0,"malfunctions":133,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KTT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2025 Q4: 133 adverse event reports received by the FDA (0 death, 51 injury, 82 malfunction and 0 other).","value":133,"unit":"device adverse event reports received","reports":133,"deaths":0,"injuries":51,"malfunctions":82,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Urethroscope (product code FGC), 2025 Q4: 131 adverse event reports received by the FDA (0 death, 0 injury, 131 malfunction and 0 other).","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":0,"malfunctions":131,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Blood Culturing (product code MDB), 2025 Q4: 130 adverse event reports received by the FDA (0 death, 0 injury, 130 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":0,"malfunctions":130,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PRL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2025 Q4: 128 adverse event reports received by the FDA (0 death, 52 injury, 76 malfunction and 0 other).","value":128,"unit":"device adverse event reports received","reports":128,"deaths":0,"injuries":52,"malfunctions":76,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2025 Q4: 126 adverse event reports received by the FDA (0 death, 10 injury, 116 malfunction and 0 other).","value":126,"unit":"device adverse event reports received","reports":126,"deaths":0,"injuries":10,"malfunctions":116,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2025 Q4: 126 adverse event reports received by the FDA (0 death, 1 injury, 125 malfunction and 0 other).","value":126,"unit":"device adverse event reports received","reports":126,"deaths":0,"injuries":1,"malfunctions":125,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2025 Q4: 126 adverse event reports received by the FDA (0 death, 126 injury, 0 malfunction and 0 other).","value":126,"unit":"device adverse event reports received","reports":126,"deaths":0,"injuries":126,"malfunctions":0,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEQ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Toothbrush, Powered (product code JEQ), 2025 Q4: 125 adverse event reports received by the FDA (0 death, 2 injury, 123 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":2,"malfunctions":123,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stent, Carotid (product code NIM), 2025 Q4: 125 adverse event reports received by the FDA (1 death, 37 injury, 87 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":1,"injuries":37,"malfunctions":87,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GZF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2025 Q4: 124 adverse event reports received by the FDA (0 death, 124 injury, 0 malfunction and 0 other).","value":124,"unit":"device adverse event reports received","reports":124,"deaths":0,"injuries":124,"malfunctions":0,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFL:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2025 Q4: 123 adverse event reports received by the FDA (0 death, 5 injury, 118 malfunction and 0 other).","value":123,"unit":"device adverse event reports received","reports":123,"deaths":0,"injuries":5,"malfunctions":118,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2025 Q4: 122 adverse event reports received by the FDA (0 death, 4 injury, 118 malfunction and 0 other).","value":122,"unit":"device adverse event reports received","reports":122,"deaths":0,"injuries":4,"malfunctions":118,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2025 Q4: 122 adverse event reports received by the FDA (0 death, 3 injury, 119 malfunction and 0 other).","value":122,"unit":"device adverse event reports received","reports":122,"deaths":0,"injuries":3,"malfunctions":119,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2025 Q4: 120 adverse event reports received by the FDA (0 death, 2 injury, 118 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":0,"injuries":2,"malfunctions":118,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZK:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2025 Q4: 119 adverse event reports received by the FDA (0 death, 119 injury, 0 malfunction and 0 other).","value":119,"unit":"device adverse event reports received","reports":119,"deaths":0,"injuries":119,"malfunctions":0,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONU:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2025 Q4: 118 adverse event reports received by the FDA (1 death, 75 injury, 42 malfunction and 0 other).","value":118,"unit":"device adverse event reports received","reports":118,"deaths":1,"injuries":75,"malfunctions":42,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2025 Q4: 117 adverse event reports received by the FDA (0 death, 63 injury, 54 malfunction and 0 other).","value":117,"unit":"device adverse event reports received","reports":117,"deaths":0,"injuries":63,"malfunctions":54,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2025 Q4: 113 adverse event reports received by the FDA (5 death, 49 injury, 58 malfunction and 1 other).","value":113,"unit":"device adverse event reports received","reports":113,"deaths":5,"injuries":49,"malfunctions":58,"other":1,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HEB:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2025 Q4: 112 adverse event reports received by the FDA (0 death, 2 injury, 110 malfunction and 0 other).","value":112,"unit":"device adverse event reports received","reports":112,"deaths":0,"injuries":2,"malfunctions":110,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NRY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2025 Q4: 109 adverse event reports received by the FDA (10 death, 32 injury, 67 malfunction and 0 other).","value":109,"unit":"device adverse event reports received","reports":109,"deaths":10,"injuries":32,"malfunctions":67,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LON:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2025 Q4: 108 adverse event reports received by the FDA (0 death, 0 injury, 108 malfunction and 0 other).","value":108,"unit":"device adverse event reports received","reports":108,"deaths":0,"injuries":0,"malfunctions":108,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2025 Q4: 107 adverse event reports received by the FDA (1 death, 9 injury, 97 malfunction and 0 other).","value":107,"unit":"device adverse event reports received","reports":107,"deaths":1,"injuries":9,"malfunctions":97,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2025 Q4: 103 adverse event reports received by the FDA (4 death, 97 injury, 2 malfunction and 0 other).","value":103,"unit":"device adverse event reports received","reports":103,"deaths":4,"injuries":97,"malfunctions":2,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCT:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2025 Q4: 101 adverse event reports received by the FDA (0 death, 1 injury, 100 malfunction and 0 other).","value":101,"unit":"device adverse event reports received","reports":101,"deaths":0,"injuries":1,"malfunctions":100,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KMY:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2025 Q4: 99 adverse event reports received by the FDA (0 death, 97 injury, 2 malfunction and 0 other).","value":99,"unit":"device adverse event reports received","reports":99,"deaths":0,"injuries":97,"malfunctions":2,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MRM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2025 Q4: 97 adverse event reports received by the FDA (0 death, 22 injury, 75 malfunction and 0 other).","value":97,"unit":"device adverse event reports received","reports":97,"deaths":0,"injuries":22,"malfunctions":75,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXC:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Clamp, Vascular (product code DXC), 2025 Q4: 94 adverse event reports received by the FDA (2 death, 13 injury, 79 malfunction and 0 other).","value":94,"unit":"device adverse event reports received","reports":94,"deaths":2,"injuries":13,"malfunctions":79,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FSA:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2025 Q4: 92 adverse event reports received by the FDA (1 death, 33 injury, 58 malfunction and 0 other).","value":92,"unit":"device adverse event reports received","reports":92,"deaths":1,"injuries":33,"malfunctions":58,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:POE:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2025 Q4: 91 adverse event reports received by the FDA (0 death, 55 injury, 36 malfunction and 0 other).","value":91,"unit":"device adverse event reports received","reports":91,"deaths":0,"injuries":55,"malfunctions":36,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OCW:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2025 Q4: 85 adverse event reports received by the FDA (2 death, 24 injury, 59 malfunction and 0 other).","value":85,"unit":"device adverse event reports received","reports":85,"deaths":2,"injuries":24,"malfunctions":59,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SCV:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SCV","deviceName":"Modular Electromechanical Surgical System","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Modular Electromechanical Surgical System (product code SCV), 2025 Q4: 84 adverse event reports received by the FDA (0 death, 3 injury, 81 malfunction and 0 other).","value":84,"unit":"device adverse event reports received","reports":84,"deaths":0,"injuries":3,"malfunctions":81,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYO:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2025 Q4: 83 adverse event reports received by the FDA (0 death, 5 injury, 78 malfunction and 0 other).","value":83,"unit":"device adverse event reports received","reports":83,"deaths":0,"injuries":5,"malfunctions":78,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KGX:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2025 Q4: 81 adverse event reports received by the FDA (0 death, 64 injury, 17 malfunction and 0 other).","value":81,"unit":"device adverse event reports received","reports":81,"deaths":0,"injuries":64,"malfunctions":17,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2025 Q4: 76 adverse event reports received by the FDA (0 death, 13 injury, 63 malfunction and 0 other).","value":76,"unit":"device adverse event reports received","reports":76,"deaths":0,"injuries":13,"malfunctions":63,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAF:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2025 Q4: 67 adverse event reports received by the FDA (2 death, 11 injury, 52 malfunction and 2 other).","value":67,"unit":"device adverse event reports received","reports":67,"deaths":2,"injuries":11,"malfunctions":52,"other":2,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QKP:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2025 Q4: 52 adverse event reports received by the FDA (0 death, 1 injury, 51 malfunction and 0 other).","value":52,"unit":"device adverse event reports received","reports":52,"deaths":0,"injuries":1,"malfunctions":51,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXN:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2025 Q4: 48 adverse event reports received by the FDA (0 death, 5 injury, 43 malfunction and 0 other).","value":48,"unit":"device adverse event reports received","reports":48,"deaths":0,"injuries":5,"malfunctions":43,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Bariatric Bed (product code OSI), 2025 Q4: 40 adverse event reports received by the FDA (0 death, 0 injury, 40 malfunction and 0 other).","value":40,"unit":"device adverse event reports received","reports":40,"deaths":0,"injuries":0,"malfunctions":40,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Compressor, Air, Portable (product code BTI), 2025 Q4: 35 adverse event reports received by the FDA (0 death, 18 injury, 17 malfunction and 0 other).","value":35,"unit":"device adverse event reports received","reports":35,"deaths":0,"injuries":18,"malfunctions":17,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITJ:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Walker, Mechanical (product code ITJ), 2025 Q4: 31 adverse event reports received by the FDA (0 death, 27 injury, 4 malfunction and 0 other).","value":31,"unit":"device adverse event reports received","reports":31,"deaths":0,"injuries":27,"malfunctions":4,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2025 Q4: 29 adverse event reports received by the FDA (4 death, 6 injury, 19 malfunction and 0 other).","value":29,"unit":"device adverse event reports received","reports":29,"deaths":4,"injuries":6,"malfunctions":19,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJH:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Orthopedic Tray (product code OJH), 2025 Q4: 25 adverse event reports received by the FDA (0 death, 14 injury, 11 malfunction and 0 other).","value":25,"unit":"device adverse event reports received","reports":25,"deaths":0,"injuries":14,"malfunctions":11,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IOR:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2025 Q4: 22 adverse event reports received by the FDA (2 death, 11 injury, 9 malfunction and 0 other).","value":22,"unit":"device adverse event reports received","reports":22,"deaths":2,"injuries":11,"malfunctions":9,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ILS:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Adaptor, Hygiene (product code ILS), 2025 Q4: 10 adverse event reports received by the FDA (0 death, 8 injury, 2 malfunction and 0 other).","value":10,"unit":"device adverse event reports received","reports":10,"deaths":0,"injuries":8,"malfunctions":2,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KZI:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KZI","deviceName":"Culture Media, Enriched","specialty":"Microbiology","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Culture Media, Enriched (product code KZI), 2025 Q4: 9 adverse event reports received by the FDA (0 death, 5 injury, 4 malfunction and 0 other).","value":9,"unit":"device adverse event reports received","reports":9,"deaths":0,"injuries":5,"malfunctions":4,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:INM:2025Q4","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"INM","deviceName":"Chair, With Casters","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q4","year":2025,"qtr":4,"periodStart":"2025-10-01","periodEnd":"2025-12-31","status":"P","text":"Chair, With Casters (product code INM), 2025 Q4: 5 adverse event reports received by the FDA (1 death, 3 injury, 1 malfunction and 0 other).","value":5,"unit":"device adverse event reports received","reports":5,"deaths":1,"injuries":3,"malfunctions":1,"other":0,"effectiveFrom":"2025-10-01","effectiveTo":"2025-12-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DZE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2025 Q3: 245,743 adverse event reports received by the FDA (1 death, 245,388 injury, 352 malfunction and 2 other).","value":245743,"unit":"device adverse event reports received","reports":245743,"deaths":1,"injuries":245388,"malfunctions":352,"other":2,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2025 Q3: 115,936 adverse event reports received by the FDA (23 death, 3,369 injury, 112,531 malfunction and 13 other).","value":115936,"unit":"device adverse event reports received","reports":115936,"deaths":23,"injuries":3369,"malfunctions":112531,"other":13,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QFG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2025 Q3: 90,150 adverse event reports received by the FDA (17 death, 11,798 injury, 78,335 malfunction and 0 other).","value":90150,"unit":"device adverse event reports received","reports":90150,"deaths":17,"injuries":11798,"malfunctions":78335,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2025 Q3: 48,601 adverse event reports received by the FDA (46 death, 5,247 injury, 43,307 malfunction and 1 other).","value":48601,"unit":"device adverse event reports received","reports":48601,"deaths":46,"injuries":5247,"malfunctions":43307,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BRY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2025 Q3: 18,176 adverse event reports received by the FDA (1 death, 3 injury, 18,172 malfunction and 0 other).","value":18176,"unit":"device adverse event reports received","reports":18176,"deaths":1,"injuries":3,"malfunctions":18172,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FRN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pump, Infusion (product code FRN), 2025 Q3: 14,667 adverse event reports received by the FDA (18 death, 150 injury, 14,482 malfunction and 17 other).","value":14667,"unit":"device adverse event reports received","reports":14667,"deaths":18,"injuries":150,"malfunctions":14482,"other":17,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PQF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2025 Q3: 11,894 adverse event reports received by the FDA (0 death, 28 injury, 11,866 malfunction and 0 other).","value":11894,"unit":"device adverse event reports received","reports":11894,"deaths":0,"injuries":28,"malfunctions":11866,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2025 Q3: 11,670 adverse event reports received by the FDA (27 death, 421 injury, 11,221 malfunction and 1 other).","value":11670,"unit":"device adverse event reports received","reports":11670,"deaths":27,"injuries":421,"malfunctions":11221,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2025 Q3: 7,900 adverse event reports received by the FDA (0 death, 7,749 injury, 151 malfunction and 0 other).","value":7900,"unit":"device adverse event reports received","reports":7900,"deaths":0,"injuries":7749,"malfunctions":151,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LGW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2025 Q3: 7,627 adverse event reports received by the FDA (6 death, 6,033 injury, 1,587 malfunction and 1 other).","value":7627,"unit":"device adverse event reports received","reports":7627,"deaths":6,"injuries":6033,"malfunctions":1587,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2025 Q3: 7,290 adverse event reports received by the FDA (1 death, 1,443 injury, 5,841 malfunction and 5 other).","value":7290,"unit":"device adverse event reports received","reports":7290,"deaths":1,"injuries":1443,"malfunctions":5841,"other":5,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2025 Q3: 6,857 adverse event reports received by the FDA (62 death, 2,965 injury, 3,829 malfunction and 1 other).","value":6857,"unit":"device adverse event reports received","reports":6857,"deaths":62,"injuries":2965,"malfunctions":3829,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2025 Q3: 6,796 adverse event reports received by the FDA (68 death, 3,654 injury, 3,074 malfunction and 0 other).","value":6796,"unit":"device adverse event reports received","reports":6796,"deaths":68,"injuries":3654,"malfunctions":3074,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2025 Q3: 6,014 adverse event reports received by the FDA (55 death, 3,353 injury, 2,604 malfunction and 2 other).","value":6014,"unit":"device adverse event reports received","reports":6014,"deaths":55,"injuries":3353,"malfunctions":2604,"other":2,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QLG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2025 Q3: 5,290 adverse event reports received by the FDA (4 death, 596 injury, 4,690 malfunction and 0 other).","value":5290,"unit":"device adverse event reports received","reports":5290,"deaths":4,"injuries":596,"malfunctions":4690,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OWB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2025 Q3: 4,680 adverse event reports received by the FDA (0 death, 16 injury, 4,664 malfunction and 0 other).","value":4680,"unit":"device adverse event reports received","reports":4680,"deaths":0,"injuries":16,"malfunctions":4664,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2025 Q3: 4,402 adverse event reports received by the FDA (2 death, 16 injury, 4,384 malfunction and 0 other).","value":4402,"unit":"device adverse event reports received","reports":4402,"deaths":2,"injuries":16,"malfunctions":4384,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKU:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2025 Q3: 4,359 adverse event reports received by the FDA (0 death, 5 injury, 4,354 malfunction and 0 other).","value":4359,"unit":"device adverse event reports received","reports":4359,"deaths":0,"injuries":5,"malfunctions":4354,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MGB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2025 Q3: 3,905 adverse event reports received by the FDA (9 death, 2,940 injury, 955 malfunction and 1 other).","value":3905,"unit":"device adverse event reports received","reports":3905,"deaths":9,"injuries":2940,"malfunctions":955,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FET:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2025 Q3: 3,713 adverse event reports received by the FDA (0 death, 10 injury, 3,703 malfunction and 0 other).","value":3713,"unit":"device adverse event reports received","reports":3713,"deaths":0,"injuries":10,"malfunctions":3703,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2025 Q3: 3,679 adverse event reports received by the FDA (27 death, 1,471 injury, 2,179 malfunction and 2 other).","value":3679,"unit":"device adverse event reports received","reports":3679,"deaths":27,"injuries":1471,"malfunctions":2179,"other":2,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OYC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2025 Q3: 3,590 adverse event reports received by the FDA (4 death, 17 injury, 3,569 malfunction and 0 other).","value":3590,"unit":"device adverse event reports received","reports":3590,"deaths":4,"injuries":17,"malfunctions":3569,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MKJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2025 Q3: 3,472 adverse event reports received by the FDA (28 death, 42 injury, 3,402 malfunction and 0 other).","value":3472,"unit":"device adverse event reports received","reports":3472,"deaths":28,"injuries":42,"malfunctions":3402,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2025 Q3: 3,430 adverse event reports received by the FDA (0 death, 15 injury, 3,415 malfunction and 0 other).","value":3430,"unit":"device adverse event reports received","reports":3430,"deaths":0,"injuries":15,"malfunctions":3415,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Staple, Implantable (product code GDW), 2025 Q3: 3,165 adverse event reports received by the FDA (18 death, 459 injury, 2,688 malfunction and 0 other).","value":3165,"unit":"device adverse event reports received","reports":3165,"deaths":18,"injuries":459,"malfunctions":2688,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BZD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2025 Q3: 3,127 adverse event reports received by the FDA (68 death, 105 injury, 2,954 malfunction and 0 other).","value":3127,"unit":"device adverse event reports received","reports":3127,"deaths":68,"injuries":105,"malfunctions":2954,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2025 Q3: 3,073 adverse event reports received by the FDA (249 death, 2,035 injury, 789 malfunction and 0 other).","value":3073,"unit":"device adverse event reports received","reports":3073,"deaths":249,"injuries":2035,"malfunctions":789,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CBK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2025 Q3: 3,023 adverse event reports received by the FDA (15 death, 56 injury, 2,952 malfunction and 0 other).","value":3023,"unit":"device adverse event reports received","reports":3023,"deaths":15,"injuries":56,"malfunctions":2952,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2025 Q3: 2,980 adverse event reports received by the FDA (0 death, 182 injury, 2,798 malfunction and 0 other).","value":2980,"unit":"device adverse event reports received","reports":2980,"deaths":0,"injuries":182,"malfunctions":2798,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MVK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2025 Q3: 2,928 adverse event reports received by the FDA (41 death, 892 injury, 1,995 malfunction and 0 other).","value":2928,"unit":"device adverse event reports received","reports":2928,"deaths":41,"injuries":892,"malfunctions":1995,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2025 Q3: 2,889 adverse event reports received by the FDA (492 death, 1,098 injury, 1,299 malfunction and 0 other).","value":2889,"unit":"device adverse event reports received","reports":2889,"deaths":492,"injuries":1098,"malfunctions":1299,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSQ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2025 Q3: 2,710 adverse event reports received by the FDA (572 death, 942 injury, 1,196 malfunction and 0 other).","value":2710,"unit":"device adverse event reports received","reports":2710,"deaths":572,"injuries":942,"malfunctions":1196,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KZI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KZI","deviceName":"Culture Media, Enriched","specialty":"Microbiology","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Culture Media, Enriched (product code KZI), 2025 Q3: 2,703 adverse event reports received by the FDA (0 death, 0 injury, 2,703 malfunction and 0 other).","value":2703,"unit":"device adverse event reports received","reports":2703,"deaths":0,"injuries":0,"malfunctions":2703,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BSZ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2025 Q3: 2,677 adverse event reports received by the FDA (1 death, 21 injury, 2,655 malfunction and 0 other).","value":2677,"unit":"device adverse event reports received","reports":2677,"deaths":1,"injuries":21,"malfunctions":2655,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2025 Q3: 2,641 adverse event reports received by the FDA (44 death, 1,038 injury, 1,559 malfunction and 0 other).","value":2641,"unit":"device adverse event reports received","reports":2641,"deaths":44,"injuries":1038,"malfunctions":1559,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2025 Q3: 2,551 adverse event reports received by the FDA (19 death, 1,385 injury, 1,146 malfunction and 1 other).","value":2551,"unit":"device adverse event reports received","reports":2551,"deaths":19,"injuries":1385,"malfunctions":1146,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FWM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2025 Q3: 2,278 adverse event reports received by the FDA (0 death, 2,261 injury, 17 malfunction and 0 other).","value":2278,"unit":"device adverse event reports received","reports":2278,"deaths":0,"injuries":2261,"malfunctions":17,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JWH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2025 Q3: 2,186 adverse event reports received by the FDA (0 death, 2,010 injury, 176 malfunction and 0 other).","value":2186,"unit":"device adverse event reports received","reports":2186,"deaths":0,"injuries":2010,"malfunctions":176,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2025 Q3: 2,074 adverse event reports received by the FDA (0 death, 265 injury, 1,809 malfunction and 0 other).","value":2074,"unit":"device adverse event reports received","reports":2074,"deaths":0,"injuries":265,"malfunctions":1809,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOQ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2025 Q3: 1,951 adverse event reports received by the FDA (7 death, 134 injury, 1,810 malfunction and 0 other).","value":1951,"unit":"device adverse event reports received","reports":1951,"deaths":7,"injuries":134,"malfunctions":1810,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2025 Q3: 1,931 adverse event reports received by the FDA (4 death, 322 injury, 1,605 malfunction and 0 other).","value":1931,"unit":"device adverse event reports received","reports":1931,"deaths":4,"injuries":322,"malfunctions":1605,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2025 Q3: 1,840 adverse event reports received by the FDA (8 death, 24 injury, 1,808 malfunction and 0 other).","value":1840,"unit":"device adverse event reports received","reports":1840,"deaths":8,"injuries":24,"malfunctions":1808,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2025 Q3: 1,773 adverse event reports received by the FDA (0 death, 1,016 injury, 757 malfunction and 0 other).","value":1773,"unit":"device adverse event reports received","reports":1773,"deaths":0,"injuries":1016,"malfunctions":757,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2025 Q3: 1,740 adverse event reports received by the FDA (1 death, 1,583 injury, 156 malfunction and 0 other).","value":1740,"unit":"device adverse event reports received","reports":1740,"deaths":1,"injuries":1583,"malfunctions":156,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JKA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2025 Q3: 1,694 adverse event reports received by the FDA (0 death, 18 injury, 1,676 malfunction and 0 other).","value":1694,"unit":"device adverse event reports received","reports":1694,"deaths":0,"injuries":18,"malfunctions":1676,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVZ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2025 Q3: 1,621 adverse event reports received by the FDA (32 death, 883 injury, 706 malfunction and 0 other).","value":1621,"unit":"device adverse event reports received","reports":1621,"deaths":32,"injuries":883,"malfunctions":706,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Blood Culturing (product code MDB), 2025 Q3: 1,590 adverse event reports received by the FDA (0 death, 0 injury, 1,590 malfunction and 0 other).","value":1590,"unit":"device adverse event reports received","reports":1590,"deaths":0,"injuries":0,"malfunctions":1590,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"General Surgery Tray (product code LRO), 2025 Q3: 1,561 adverse event reports received by the FDA (0 death, 62 injury, 1,499 malfunction and 0 other).","value":1561,"unit":"device adverse event reports received","reports":1561,"deaths":0,"injuries":62,"malfunctions":1499,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2025 Q3: 1,545 adverse event reports received by the FDA (2 death, 81 injury, 1,462 malfunction and 0 other).","value":1545,"unit":"device adverse event reports received","reports":1545,"deaths":2,"injuries":81,"malfunctions":1462,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LKK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2025 Q3: 1,454 adverse event reports received by the FDA (0 death, 644 injury, 810 malfunction and 0 other).","value":1454,"unit":"device adverse event reports received","reports":1454,"deaths":0,"injuries":644,"malfunctions":810,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2025 Q3: 1,347 adverse event reports received by the FDA (26 death, 947 injury, 374 malfunction and 0 other).","value":1347,"unit":"device adverse event reports received","reports":1347,"deaths":26,"injuries":947,"malfunctions":374,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Intraocular Lens (product code HQL), 2025 Q3: 1,331 adverse event reports received by the FDA (0 death, 267 injury, 1,064 malfunction and 0 other).","value":1331,"unit":"device adverse event reports received","reports":1331,"deaths":0,"injuries":267,"malfunctions":1064,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Implant, Cochlear (product code MCM), 2025 Q3: 1,308 adverse event reports received by the FDA (1 death, 767 injury, 540 malfunction and 0 other).","value":1308,"unit":"device adverse event reports received","reports":1308,"deaths":1,"injuries":767,"malfunctions":540,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2025 Q3: 1,301 adverse event reports received by the FDA (0 death, 51 injury, 1,250 malfunction and 0 other).","value":1301,"unit":"device adverse event reports received","reports":1301,"deaths":0,"injuries":51,"malfunctions":1250,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXG","deviceName":"Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (product code LXG), 2025 Q3: 1,249 adverse event reports received by the FDA (0 death, 0 injury, 1,249 malfunction and 0 other).","value":1249,"unit":"device adverse event reports received","reports":1249,"deaths":0,"injuries":0,"malfunctions":1249,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FOZ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2025 Q3: 1,239 adverse event reports received by the FDA (2 death, 53 injury, 1,183 malfunction and 1 other).","value":1239,"unit":"device adverse event reports received","reports":1239,"deaths":2,"injuries":53,"malfunctions":1183,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Leadless Pacemaker (product code PNJ), 2025 Q3: 1,235 adverse event reports received by the FDA (58 death, 507 injury, 670 malfunction and 0 other).","value":1235,"unit":"device adverse event reports received","reports":1235,"deaths":58,"injuries":507,"malfunctions":670,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2025 Q3: 1,204 adverse event reports received by the FDA (1 death, 77 injury, 1,125 malfunction and 1 other).","value":1204,"unit":"device adverse event reports received","reports":1204,"deaths":1,"injuries":77,"malfunctions":1125,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2025 Q3: 1,196 adverse event reports received by the FDA (0 death, 123 injury, 1,073 malfunction and 0 other).","value":1196,"unit":"device adverse event reports received","reports":1196,"deaths":0,"injuries":123,"malfunctions":1073,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Steerable (product code DRA), 2025 Q3: 1,170 adverse event reports received by the FDA (11 death, 211 injury, 948 malfunction and 0 other).","value":1170,"unit":"device adverse event reports received","reports":1170,"deaths":11,"injuries":211,"malfunctions":948,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QZI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2025 Q3: 1,143 adverse event reports received by the FDA (32 death, 510 injury, 600 malfunction and 1 other).","value":1143,"unit":"device adverse event reports received","reports":1143,"deaths":32,"injuries":510,"malfunctions":600,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Introducer, Catheter (product code DYB), 2025 Q3: 1,115 adverse event reports received by the FDA (20 death, 272 injury, 823 malfunction and 0 other).","value":1115,"unit":"device adverse event reports received","reports":1115,"deaths":20,"injuries":272,"malfunctions":823,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JJE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2025 Q3: 1,115 adverse event reports received by the FDA (0 death, 22 injury, 1,092 malfunction and 1 other).","value":1115,"unit":"device adverse event reports received","reports":1115,"deaths":0,"injuries":22,"malfunctions":1092,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2025 Q3: 1,113 adverse event reports received by the FDA (2 death, 155 injury, 956 malfunction and 0 other).","value":1113,"unit":"device adverse event reports received","reports":1113,"deaths":2,"injuries":155,"malfunctions":956,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2025 Q3: 1,100 adverse event reports received by the FDA (2 death, 58 injury, 1,040 malfunction and 0 other).","value":1100,"unit":"device adverse event reports received","reports":1100,"deaths":2,"injuries":58,"malfunctions":1040,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Syringe, Piston (product code FMF), 2025 Q3: 1,084 adverse event reports received by the FDA (0 death, 91 injury, 992 malfunction and 1 other).","value":1084,"unit":"device adverse event reports received","reports":1084,"deaths":0,"injuries":91,"malfunctions":992,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2025 Q3: 1,051 adverse event reports received by the FDA (0 death, 115 injury, 936 malfunction and 0 other).","value":1051,"unit":"device adverse event reports received","reports":1051,"deaths":0,"injuries":115,"malfunctions":936,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2025 Q3: 1,039 adverse event reports received by the FDA (24 death, 172 injury, 843 malfunction and 0 other).","value":1039,"unit":"device adverse event reports received","reports":1039,"deaths":24,"injuries":172,"malfunctions":843,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2025 Q3: 1,008 adverse event reports received by the FDA (0 death, 15 injury, 993 malfunction and 0 other).","value":1008,"unit":"device adverse event reports received","reports":1008,"deaths":0,"injuries":15,"malfunctions":993,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NGV:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2025 Q3: 998 adverse event reports received by the FDA (160 death, 802 injury, 36 malfunction and 0 other).","value":998,"unit":"device adverse event reports received","reports":998,"deaths":160,"injuries":802,"malfunctions":36,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2025 Q3: 994 adverse event reports received by the FDA (0 death, 69 injury, 925 malfunction and 0 other).","value":994,"unit":"device adverse event reports received","reports":994,"deaths":0,"injuries":69,"malfunctions":925,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HET:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2025 Q3: 924 adverse event reports received by the FDA (0 death, 1 injury, 923 malfunction and 0 other).","value":924,"unit":"device adverse event reports received","reports":924,"deaths":0,"injuries":1,"malfunctions":923,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Replacement Heart-Valve (product code DYE), 2025 Q3: 897 adverse event reports received by the FDA (9 death, 864 injury, 24 malfunction and 0 other).","value":897,"unit":"device adverse event reports received","reports":897,"deaths":9,"injuries":864,"malfunctions":24,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2025 Q3: 881 adverse event reports received by the FDA (1 death, 763 injury, 117 malfunction and 0 other).","value":881,"unit":"device adverse event reports received","reports":881,"deaths":1,"injuries":763,"malfunctions":117,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2025 Q3: 873 adverse event reports received by the FDA (13 death, 805 injury, 55 malfunction and 0 other).","value":873,"unit":"device adverse event reports received","reports":873,"deaths":13,"injuries":805,"malfunctions":55,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2025 Q3: 864 adverse event reports received by the FDA (7 death, 469 injury, 388 malfunction and 0 other).","value":864,"unit":"device adverse event reports received","reports":864,"deaths":7,"injuries":469,"malfunctions":388,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2025 Q3: 854 adverse event reports received by the FDA (1 death, 425 injury, 428 malfunction and 0 other).","value":854,"unit":"device adverse event reports received","reports":854,"deaths":1,"injuries":425,"malfunctions":428,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2025 Q3: 825 adverse event reports received by the FDA (5 death, 56 injury, 764 malfunction and 0 other).","value":825,"unit":"device adverse event reports received","reports":825,"deaths":5,"injuries":56,"malfunctions":764,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2025 Q3: 808 adverse event reports received by the FDA (0 death, 2 injury, 806 malfunction and 0 other).","value":808,"unit":"device adverse event reports received","reports":808,"deaths":0,"injuries":2,"malfunctions":806,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FKX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2025 Q3: 788 adverse event reports received by the FDA (24 death, 281 injury, 483 malfunction and 0 other).","value":788,"unit":"device adverse event reports received","reports":788,"deaths":24,"injuries":281,"malfunctions":483,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MIH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2025 Q3: 787 adverse event reports received by the FDA (30 death, 578 injury, 179 malfunction and 0 other).","value":787,"unit":"device adverse event reports received","reports":787,"deaths":30,"injuries":578,"malfunctions":179,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FJK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2025 Q3: 786 adverse event reports received by the FDA (3 death, 7 injury, 776 malfunction and 0 other).","value":786,"unit":"device adverse event reports received","reports":786,"deaths":3,"injuries":7,"malfunctions":776,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PHX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2025 Q3: 774 adverse event reports received by the FDA (9 death, 671 injury, 94 malfunction and 0 other).","value":774,"unit":"device adverse event reports received","reports":774,"deaths":9,"injuries":671,"malfunctions":94,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Percutaneous (product code DQY), 2025 Q3: 757 adverse event reports received by the FDA (23 death, 178 injury, 555 malfunction and 1 other).","value":757,"unit":"device adverse event reports received","reports":757,"deaths":23,"injuries":178,"malfunctions":555,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2025 Q3: 753 adverse event reports received by the FDA (3 death, 135 injury, 614 malfunction and 1 other).","value":753,"unit":"device adverse event reports received","reports":753,"deaths":3,"injuries":135,"malfunctions":614,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2025 Q3: 745 adverse event reports received by the FDA (0 death, 44 injury, 701 malfunction and 0 other).","value":745,"unit":"device adverse event reports received","reports":745,"deaths":0,"injuries":44,"malfunctions":701,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2025 Q3: 744 adverse event reports received by the FDA (2 death, 134 injury, 608 malfunction and 0 other).","value":744,"unit":"device adverse event reports received","reports":744,"deaths":2,"injuries":134,"malfunctions":608,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2025 Q3: 742 adverse event reports received by the FDA (2 death, 6 injury, 734 malfunction and 0 other).","value":742,"unit":"device adverse event reports received","reports":742,"deaths":2,"injuries":6,"malfunctions":734,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2025 Q3: 736 adverse event reports received by the FDA (0 death, 14 injury, 722 malfunction and 0 other).","value":736,"unit":"device adverse event reports received","reports":736,"deaths":0,"injuries":14,"malfunctions":722,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2025 Q3: 730 adverse event reports received by the FDA (6 death, 54 injury, 669 malfunction and 1 other).","value":730,"unit":"device adverse event reports received","reports":730,"deaths":6,"injuries":54,"malfunctions":669,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2025 Q3: 726 adverse event reports received by the FDA (0 death, 89 injury, 637 malfunction and 0 other).","value":726,"unit":"device adverse event reports received","reports":726,"deaths":0,"injuries":89,"malfunctions":637,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2025 Q3: 709 adverse event reports received by the FDA (0 death, 20 injury, 689 malfunction and 0 other).","value":709,"unit":"device adverse event reports received","reports":709,"deaths":0,"injuries":20,"malfunctions":689,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2025 Q3: 704 adverse event reports received by the FDA (2 death, 287 injury, 415 malfunction and 0 other).","value":704,"unit":"device adverse event reports received","reports":704,"deaths":2,"injuries":287,"malfunctions":415,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OLO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2025 Q3: 690 adverse event reports received by the FDA (0 death, 84 injury, 606 malfunction and 0 other).","value":690,"unit":"device adverse event reports received","reports":690,"deaths":0,"injuries":84,"malfunctions":606,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ODG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2025 Q3: 682 adverse event reports received by the FDA (2 death, 13 injury, 667 malfunction and 0 other).","value":682,"unit":"device adverse event reports received","reports":682,"deaths":2,"injuries":13,"malfunctions":667,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2025 Q3: 674 adverse event reports received by the FDA (1 death, 39 injury, 634 malfunction and 0 other).","value":674,"unit":"device adverse event reports received","reports":674,"deaths":1,"injuries":39,"malfunctions":634,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IZI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2025 Q3: 670 adverse event reports received by the FDA (0 death, 1 injury, 668 malfunction and 1 other).","value":670,"unit":"device adverse event reports received","reports":670,"deaths":0,"injuries":1,"malfunctions":668,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2025 Q3: 669 adverse event reports received by the FDA (0 death, 431 injury, 238 malfunction and 0 other).","value":669,"unit":"device adverse event reports received","reports":669,"deaths":0,"injuries":431,"malfunctions":238,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIQ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2025 Q3: 655 adverse event reports received by the FDA (69 death, 280 injury, 306 malfunction and 0 other).","value":655,"unit":"device adverse event reports received","reports":655,"deaths":69,"injuries":280,"malfunctions":306,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2025 Q3: 641 adverse event reports received by the FDA (32 death, 363 injury, 246 malfunction and 0 other).","value":641,"unit":"device adverse event reports received","reports":641,"deaths":32,"injuries":363,"malfunctions":246,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NZU:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2025 Q3: 636 adverse event reports received by the FDA (0 death, 149 injury, 487 malfunction and 0 other).","value":636,"unit":"device adverse event reports received","reports":636,"deaths":0,"injuries":149,"malfunctions":487,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Thermal Regulating (product code DWJ), 2025 Q3: 622 adverse event reports received by the FDA (0 death, 13 injury, 609 malfunction and 0 other).","value":622,"unit":"device adverse event reports received","reports":622,"deaths":0,"injuries":13,"malfunctions":609,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FHW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2025 Q3: 622 adverse event reports received by the FDA (0 death, 587 injury, 35 malfunction and 0 other).","value":622,"unit":"device adverse event reports received","reports":622,"deaths":0,"injuries":587,"malfunctions":35,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2025 Q3: 611 adverse event reports received by the FDA (0 death, 3 injury, 608 malfunction and 0 other).","value":611,"unit":"device adverse event reports received","reports":611,"deaths":0,"injuries":3,"malfunctions":608,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NEW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2025 Q3: 607 adverse event reports received by the FDA (0 death, 93 injury, 514 malfunction and 0 other).","value":607,"unit":"device adverse event reports received","reports":607,"deaths":0,"injuries":93,"malfunctions":514,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2025 Q3: 605 adverse event reports received by the FDA (4 death, 449 injury, 152 malfunction and 0 other).","value":605,"unit":"device adverse event reports received","reports":605,"deaths":4,"injuries":449,"malfunctions":152,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2025 Q3: 592 adverse event reports received by the FDA (0 death, 32 injury, 560 malfunction and 0 other).","value":592,"unit":"device adverse event reports received","reports":592,"deaths":0,"injuries":32,"malfunctions":560,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LIT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2025 Q3: 575 adverse event reports received by the FDA (1 death, 56 injury, 518 malfunction and 0 other).","value":575,"unit":"device adverse event reports received","reports":575,"deaths":1,"injuries":56,"malfunctions":518,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2025 Q3: 567 adverse event reports received by the FDA (11 death, 193 injury, 363 malfunction and 0 other).","value":567,"unit":"device adverse event reports received","reports":567,"deaths":11,"injuries":193,"malfunctions":363,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2025 Q3: 558 adverse event reports received by the FDA (3 death, 11 injury, 544 malfunction and 0 other).","value":558,"unit":"device adverse event reports received","reports":558,"deaths":3,"injuries":11,"malfunctions":544,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2025 Q3: 548 adverse event reports received by the FDA (0 death, 544 injury, 4 malfunction and 0 other).","value":548,"unit":"device adverse event reports received","reports":548,"deaths":0,"injuries":544,"malfunctions":4,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2025 Q3: 542 adverse event reports received by the FDA (1 death, 489 injury, 52 malfunction and 0 other).","value":542,"unit":"device adverse event reports received","reports":542,"deaths":1,"injuries":489,"malfunctions":52,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NXC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Aligner, Sequential (product code NXC), 2025 Q3: 536 adverse event reports received by the FDA (0 death, 518 injury, 18 malfunction and 0 other).","value":536,"unit":"device adverse event reports received","reports":536,"deaths":0,"injuries":518,"malfunctions":18,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2025 Q3: 534 adverse event reports received by the FDA (9 death, 223 injury, 302 malfunction and 0 other).","value":534,"unit":"device adverse event reports received","reports":534,"deaths":9,"injuries":223,"malfunctions":302,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2025 Q3: 517 adverse event reports received by the FDA (0 death, 119 injury, 398 malfunction and 0 other).","value":517,"unit":"device adverse event reports received","reports":517,"deaths":0,"injuries":119,"malfunctions":398,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MOM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2025 Q3: 514 adverse event reports received by the FDA (2 death, 186 injury, 326 malfunction and 0 other).","value":514,"unit":"device adverse event reports received","reports":514,"deaths":2,"injuries":186,"malfunctions":326,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Clip, Implantable (product code FZP), 2025 Q3: 500 adverse event reports received by the FDA (0 death, 20 injury, 480 malfunction and 0 other).","value":500,"unit":"device adverse event reports received","reports":500,"deaths":0,"injuries":20,"malfunctions":480,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Instrument, Biopsy (product code KNW), 2025 Q3: 500 adverse event reports received by the FDA (0 death, 71 injury, 429 malfunction and 0 other).","value":500,"unit":"device adverse event reports received","reports":500,"deaths":0,"injuries":71,"malfunctions":429,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2025 Q3: 497 adverse event reports received by the FDA (1 death, 90 injury, 406 malfunction and 0 other).","value":497,"unit":"device adverse event reports received","reports":497,"deaths":1,"injuries":90,"malfunctions":406,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2025 Q3: 491 adverse event reports received by the FDA (4 death, 73 injury, 414 malfunction and 0 other).","value":491,"unit":"device adverse event reports received","reports":491,"deaths":4,"injuries":73,"malfunctions":414,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PMP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2025 Q3: 481 adverse event reports received by the FDA (0 death, 479 injury, 2 malfunction and 0 other).","value":481,"unit":"device adverse event reports received","reports":481,"deaths":0,"injuries":479,"malfunctions":2,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HXX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Screwdriver (product code HXX), 2025 Q3: 480 adverse event reports received by the FDA (0 death, 4 injury, 476 malfunction and 0 other).","value":480,"unit":"device adverse event reports received","reports":480,"deaths":0,"injuries":4,"malfunctions":476,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LMH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2025 Q3: 479 adverse event reports received by the FDA (0 death, 478 injury, 1 malfunction and 0 other).","value":479,"unit":"device adverse event reports received","reports":479,"deaths":0,"injuries":478,"malfunctions":1,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2025 Q3: 479 adverse event reports received by the FDA (0 death, 7 injury, 472 malfunction and 0 other).","value":479,"unit":"device adverse event reports received","reports":479,"deaths":0,"injuries":7,"malfunctions":472,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2025 Q3: 478 adverse event reports received by the FDA (8 death, 444 injury, 26 malfunction and 0 other).","value":478,"unit":"device adverse event reports received","reports":478,"deaths":8,"injuries":444,"malfunctions":26,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Arthroscope (product code HRX), 2025 Q3: 475 adverse event reports received by the FDA (0 death, 14 injury, 461 malfunction and 0 other).","value":475,"unit":"device adverse event reports received","reports":475,"deaths":0,"injuries":14,"malfunctions":461,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Impactor (product code HWA), 2025 Q3: 466 adverse event reports received by the FDA (0 death, 1 injury, 465 malfunction and 0 other).","value":466,"unit":"device adverse event reports received","reports":466,"deaths":0,"injuries":1,"malfunctions":465,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2025 Q3: 460 adverse event reports received by the FDA (0 death, 11 injury, 449 malfunction and 0 other).","value":460,"unit":"device adverse event reports received","reports":460,"deaths":0,"injuries":11,"malfunctions":449,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2025 Q3: 460 adverse event reports received by the FDA (7 death, 164 injury, 289 malfunction and 0 other).","value":460,"unit":"device adverse event reports received","reports":460,"deaths":7,"injuries":164,"malfunctions":289,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Template (product code HWT), 2025 Q3: 453 adverse event reports received by the FDA (0 death, 4 injury, 449 malfunction and 0 other).","value":453,"unit":"device adverse event reports received","reports":453,"deaths":0,"injuries":4,"malfunctions":449,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2025 Q3: 445 adverse event reports received by the FDA (1 death, 62 injury, 382 malfunction and 0 other).","value":445,"unit":"device adverse event reports received","reports":445,"deaths":1,"injuries":62,"malfunctions":382,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2025 Q3: 435 adverse event reports received by the FDA (1 death, 31 injury, 403 malfunction and 0 other).","value":435,"unit":"device adverse event reports received","reports":435,"deaths":1,"injuries":31,"malfunctions":403,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2025 Q3: 435 adverse event reports received by the FDA (0 death, 0 injury, 435 malfunction and 0 other).","value":435,"unit":"device adverse event reports received","reports":435,"deaths":0,"injuries":0,"malfunctions":435,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MZF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Test, Hiv Detection (product code MZF), 2025 Q3: 431 adverse event reports received by the FDA (0 death, 7 injury, 424 malfunction and 0 other).","value":431,"unit":"device adverse event reports received","reports":431,"deaths":0,"injuries":7,"malfunctions":424,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2025 Q3: 427 adverse event reports received by the FDA (0 death, 357 injury, 70 malfunction and 0 other).","value":427,"unit":"device adverse event reports received","reports":427,"deaths":0,"injuries":357,"malfunctions":70,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2025 Q3: 422 adverse event reports received by the FDA (4 death, 78 injury, 340 malfunction and 0 other).","value":422,"unit":"device adverse event reports received","reports":422,"deaths":4,"injuries":78,"malfunctions":340,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Reamer (product code HTO), 2025 Q3: 419 adverse event reports received by the FDA (0 death, 0 injury, 419 malfunction and 0 other).","value":419,"unit":"device adverse event reports received","reports":419,"deaths":0,"injuries":0,"malfunctions":419,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JDI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2025 Q3: 418 adverse event reports received by the FDA (2 death, 392 injury, 24 malfunction and 0 other).","value":418,"unit":"device adverse event reports received","reports":418,"deaths":2,"injuries":392,"malfunctions":24,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LON:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2025 Q3: 418 adverse event reports received by the FDA (0 death, 0 injury, 418 malfunction and 0 other).","value":418,"unit":"device adverse event reports received","reports":418,"deaths":0,"injuries":0,"malfunctions":418,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FQH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Lavage, Jet (product code FQH), 2025 Q3: 417 adverse event reports received by the FDA (0 death, 5 injury, 412 malfunction and 0 other).","value":417,"unit":"device adverse event reports received","reports":417,"deaths":0,"injuries":5,"malfunctions":412,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2025 Q3: 408 adverse event reports received by the FDA (0 death, 7 injury, 401 malfunction and 0 other).","value":408,"unit":"device adverse event reports received","reports":408,"deaths":0,"injuries":7,"malfunctions":401,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PSV:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2025 Q3: 404 adverse event reports received by the FDA (0 death, 8 injury, 396 malfunction and 0 other).","value":404,"unit":"device adverse event reports received","reports":404,"deaths":0,"injuries":8,"malfunctions":396,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LOX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2025 Q3: 403 adverse event reports received by the FDA (12 death, 39 injury, 352 malfunction and 0 other).","value":403,"unit":"device adverse event reports received","reports":403,"deaths":12,"injuries":39,"malfunctions":352,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QCB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2025 Q3: 395 adverse event reports received by the FDA (0 death, 395 injury, 0 malfunction and 0 other).","value":395,"unit":"device adverse event reports received","reports":395,"deaths":0,"injuries":395,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ETN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Nerve (product code ETN), 2025 Q3: 387 adverse event reports received by the FDA (0 death, 11 injury, 376 malfunction and 0 other).","value":387,"unit":"device adverse event reports received","reports":387,"deaths":0,"injuries":11,"malfunctions":376,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Bit, Drill (product code HTW), 2025 Q3: 385 adverse event reports received by the FDA (0 death, 23 injury, 362 malfunction and 0 other).","value":385,"unit":"device adverse event reports received","reports":385,"deaths":0,"injuries":23,"malfunctions":362,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GBX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Irrigation (product code GBX), 2025 Q3: 383 adverse event reports received by the FDA (0 death, 30 injury, 353 malfunction and 0 other).","value":383,"unit":"device adverse event reports received","reports":383,"deaths":0,"injuries":30,"malfunctions":353,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JCW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2025 Q3: 383 adverse event reports received by the FDA (0 death, 364 injury, 19 malfunction and 0 other).","value":383,"unit":"device adverse event reports received","reports":383,"deaths":0,"injuries":364,"malfunctions":19,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2025 Q3: 382 adverse event reports received by the FDA (0 death, 164 injury, 218 malfunction and 0 other).","value":382,"unit":"device adverse event reports received","reports":382,"deaths":0,"injuries":164,"malfunctions":218,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2025 Q3: 377 adverse event reports received by the FDA (5 death, 217 injury, 155 malfunction and 0 other).","value":377,"unit":"device adverse event reports received","reports":377,"deaths":5,"injuries":217,"malfunctions":155,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2025 Q3: 375 adverse event reports received by the FDA (0 death, 1 injury, 374 malfunction and 0 other).","value":375,"unit":"device adverse event reports received","reports":375,"deaths":0,"injuries":1,"malfunctions":374,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2025 Q3: 373 adverse event reports received by the FDA (0 death, 47 injury, 326 malfunction and 0 other).","value":373,"unit":"device adverse event reports received","reports":373,"deaths":0,"injuries":47,"malfunctions":326,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2025 Q3: 371 adverse event reports received by the FDA (0 death, 7 injury, 364 malfunction and 0 other).","value":371,"unit":"device adverse event reports received","reports":371,"deaths":0,"injuries":7,"malfunctions":364,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OUT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2025 Q3: 370 adverse event reports received by the FDA (4 death, 66 injury, 300 malfunction and 0 other).","value":370,"unit":"device adverse event reports received","reports":370,"deaths":4,"injuries":66,"malfunctions":300,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OAE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2025 Q3: 364 adverse event reports received by the FDA (11 death, 181 injury, 172 malfunction and 0 other).","value":364,"unit":"device adverse event reports received","reports":364,"deaths":11,"injuries":181,"malfunctions":172,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LYJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2025 Q3: 352 adverse event reports received by the FDA (18 death, 125 injury, 209 malfunction and 0 other).","value":352,"unit":"device adverse event reports received","reports":352,"deaths":18,"injuries":125,"malfunctions":209,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2025 Q3: 347 adverse event reports received by the FDA (0 death, 88 injury, 259 malfunction and 0 other).","value":347,"unit":"device adverse event reports received","reports":347,"deaths":0,"injuries":88,"malfunctions":259,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2025 Q3: 345 adverse event reports received by the FDA (6 death, 184 injury, 155 malfunction and 0 other).","value":345,"unit":"device adverse event reports received","reports":345,"deaths":6,"injuries":184,"malfunctions":155,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2025 Q3: 339 adverse event reports received by the FDA (0 death, 11 injury, 328 malfunction and 0 other).","value":339,"unit":"device adverse event reports received","reports":339,"deaths":0,"injuries":11,"malfunctions":328,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MND:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ligator, Esophageal (product code MND), 2025 Q3: 334 adverse event reports received by the FDA (3 death, 17 injury, 314 malfunction and 0 other).","value":334,"unit":"device adverse event reports received","reports":334,"deaths":3,"injuries":17,"malfunctions":314,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ERL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2025 Q3: 332 adverse event reports received by the FDA (0 death, 2 injury, 330 malfunction and 0 other).","value":332,"unit":"device adverse event reports received","reports":332,"deaths":0,"injuries":2,"malfunctions":330,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SAF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2025 Q3: 329 adverse event reports received by the FDA (0 death, 30 injury, 299 malfunction and 0 other).","value":329,"unit":"device adverse event reports received","reports":329,"deaths":0,"injuries":30,"malfunctions":299,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Plate, Bone (product code JEY), 2025 Q3: 327 adverse event reports received by the FDA (0 death, 26 injury, 301 malfunction and 0 other).","value":327,"unit":"device adverse event reports received","reports":327,"deaths":0,"injuries":26,"malfunctions":301,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MFK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2025 Q3: 320 adverse event reports received by the FDA (0 death, 229 injury, 91 malfunction and 0 other).","value":320,"unit":"device adverse event reports received","reports":320,"deaths":0,"injuries":229,"malfunctions":91,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SBA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2025 Q3: 313 adverse event reports received by the FDA (0 death, 77 injury, 236 malfunction and 0 other).","value":313,"unit":"device adverse event reports received","reports":313,"deaths":0,"injuries":77,"malfunctions":236,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2025 Q3: 311 adverse event reports received by the FDA (0 death, 3 injury, 308 malfunction and 0 other).","value":311,"unit":"device adverse event reports received","reports":311,"deaths":0,"injuries":3,"malfunctions":308,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2025 Q3: 311 adverse event reports received by the FDA (0 death, 6 injury, 301 malfunction and 4 other).","value":311,"unit":"device adverse event reports received","reports":311,"deaths":0,"injuries":6,"malfunctions":301,"other":4,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2025 Q3: 302 adverse event reports received by the FDA (0 death, 296 injury, 6 malfunction and 0 other).","value":302,"unit":"device adverse event reports received","reports":302,"deaths":0,"injuries":296,"malfunctions":6,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KOD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Urological (product code KOD), 2025 Q3: 301 adverse event reports received by the FDA (0 death, 29 injury, 272 malfunction and 0 other).","value":301,"unit":"device adverse event reports received","reports":301,"deaths":0,"injuries":29,"malfunctions":272,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JXG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2025 Q3: 299 adverse event reports received by the FDA (2 death, 193 injury, 104 malfunction and 0 other).","value":299,"unit":"device adverse event reports received","reports":299,"deaths":2,"injuries":193,"malfunctions":104,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2025 Q3: 296 adverse event reports received by the FDA (0 death, 291 injury, 5 malfunction and 0 other).","value":296,"unit":"device adverse event reports received","reports":296,"deaths":0,"injuries":291,"malfunctions":5,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTQ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2025 Q3: 293 adverse event reports received by the FDA (5 death, 5 injury, 283 malfunction and 0 other).","value":293,"unit":"device adverse event reports received","reports":293,"deaths":5,"injuries":5,"malfunctions":283,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2025 Q3: 293 adverse event reports received by the FDA (0 death, 289 injury, 4 malfunction and 0 other).","value":293,"unit":"device adverse event reports received","reports":293,"deaths":0,"injuries":289,"malfunctions":4,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Driver, Prosthesis (product code HWR), 2025 Q3: 290 adverse event reports received by the FDA (0 death, 2 injury, 288 malfunction and 0 other).","value":290,"unit":"device adverse event reports received","reports":290,"deaths":0,"injuries":2,"malfunctions":288,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2025 Q3: 289 adverse event reports received by the FDA (2 death, 185 injury, 102 malfunction and 0 other).","value":289,"unit":"device adverse event reports received","reports":289,"deaths":2,"injuries":185,"malfunctions":102,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2025 Q3: 289 adverse event reports received by the FDA (15 death, 120 injury, 154 malfunction and 0 other).","value":289,"unit":"device adverse event reports received","reports":289,"deaths":15,"injuries":120,"malfunctions":154,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LHI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2025 Q3: 287 adverse event reports received by the FDA (0 death, 1 injury, 286 malfunction and 0 other).","value":287,"unit":"device adverse event reports received","reports":287,"deaths":0,"injuries":1,"malfunctions":286,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2025 Q3: 285 adverse event reports received by the FDA (0 death, 32 injury, 253 malfunction and 0 other).","value":285,"unit":"device adverse event reports received","reports":285,"deaths":0,"injuries":32,"malfunctions":253,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PFO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2025 Q3: 283 adverse event reports received by the FDA (0 death, 249 injury, 34 malfunction and 0 other).","value":283,"unit":"device adverse event reports received","reports":283,"deaths":0,"injuries":249,"malfunctions":34,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NOU:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2025 Q3: 282 adverse event reports received by the FDA (4 death, 24 injury, 254 malfunction and 0 other).","value":282,"unit":"device adverse event reports received","reports":282,"deaths":4,"injuries":24,"malfunctions":254,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2025 Q3: 281 adverse event reports received by the FDA (0 death, 41 injury, 240 malfunction and 0 other).","value":281,"unit":"device adverse event reports received","reports":281,"deaths":0,"injuries":41,"malfunctions":240,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Coude (product code EZC), 2025 Q3: 264 adverse event reports received by the FDA (0 death, 20 injury, 244 malfunction and 0 other).","value":264,"unit":"device adverse event reports received","reports":264,"deaths":0,"injuries":20,"malfunctions":244,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2025 Q3: 263 adverse event reports received by the FDA (5 death, 17 injury, 241 malfunction and 0 other).","value":263,"unit":"device adverse event reports received","reports":263,"deaths":5,"injuries":17,"malfunctions":241,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2025 Q3: 262 adverse event reports received by the FDA (0 death, 27 injury, 235 malfunction and 0 other).","value":262,"unit":"device adverse event reports received","reports":262,"deaths":0,"injuries":27,"malfunctions":235,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTZ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2025 Q3: 261 adverse event reports received by the FDA (13 death, 16 injury, 232 malfunction and 0 other).","value":261,"unit":"device adverse event reports received","reports":261,"deaths":13,"injuries":16,"malfunctions":232,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stapler, Surgical (product code GAG), 2025 Q3: 258 adverse event reports received by the FDA (0 death, 22 injury, 236 malfunction and 0 other).","value":258,"unit":"device adverse event reports received","reports":258,"deaths":0,"injuries":22,"malfunctions":236,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2025 Q3: 257 adverse event reports received by the FDA (4 death, 30 injury, 223 malfunction and 0 other).","value":257,"unit":"device adverse event reports received","reports":257,"deaths":4,"injuries":30,"malfunctions":223,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2025 Q3: 254 adverse event reports received by the FDA (0 death, 5 injury, 249 malfunction and 0 other).","value":254,"unit":"device adverse event reports received","reports":254,"deaths":0,"injuries":5,"malfunctions":249,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTC","deviceName":"Analyzer, Pacemaker Generator Function","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Analyzer, Pacemaker Generator Function (product code DTC), 2025 Q3: 249 adverse event reports received by the FDA (0 death, 2 injury, 247 malfunction and 0 other).","value":249,"unit":"device adverse event reports received","reports":249,"deaths":0,"injuries":2,"malfunctions":247,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2025 Q3: 249 adverse event reports received by the FDA (5 death, 53 injury, 191 malfunction and 0 other).","value":249,"unit":"device adverse event reports received","reports":249,"deaths":5,"injuries":53,"malfunctions":191,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Programmer, Pacemaker (product code KRG), 2025 Q3: 247 adverse event reports received by the FDA (0 death, 6 injury, 241 malfunction and 0 other).","value":247,"unit":"device adverse event reports received","reports":247,"deaths":0,"injuries":6,"malfunctions":241,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2025 Q3: 245 adverse event reports received by the FDA (1 death, 17 injury, 227 malfunction and 0 other).","value":245,"unit":"device adverse event reports received","reports":245,"deaths":1,"injuries":17,"malfunctions":227,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2025 Q3: 241 adverse event reports received by the FDA (5 death, 12 injury, 224 malfunction and 0 other).","value":241,"unit":"device adverse event reports received","reports":241,"deaths":5,"injuries":12,"malfunctions":224,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2025 Q3: 240 adverse event reports received by the FDA (11 death, 149 injury, 80 malfunction and 0 other).","value":240,"unit":"device adverse event reports received","reports":240,"deaths":11,"injuries":149,"malfunctions":80,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2025 Q3: 238 adverse event reports received by the FDA (17 death, 72 injury, 149 malfunction and 0 other).","value":238,"unit":"device adverse event reports received","reports":238,"deaths":17,"injuries":72,"malfunctions":149,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNQ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2025 Q3: 233 adverse event reports received by the FDA (0 death, 229 injury, 4 malfunction and 0 other).","value":233,"unit":"device adverse event reports received","reports":233,"deaths":0,"injuries":229,"malfunctions":4,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GWF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2025 Q3: 229 adverse event reports received by the FDA (0 death, 4 injury, 225 malfunction and 0 other).","value":229,"unit":"device adverse event reports received","reports":229,"deaths":0,"injuries":4,"malfunctions":225,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MLV:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2025 Q3: 227 adverse event reports received by the FDA (5 death, 94 injury, 128 malfunction and 0 other).","value":227,"unit":"device adverse event reports received","reports":227,"deaths":5,"injuries":94,"malfunctions":128,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NHA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2025 Q3: 224 adverse event reports received by the FDA (0 death, 61 injury, 163 malfunction and 0 other).","value":224,"unit":"device adverse event reports received","reports":224,"deaths":0,"injuries":61,"malfunctions":163,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2025 Q3: 218 adverse event reports received by the FDA (5 death, 4 injury, 209 malfunction and 0 other).","value":218,"unit":"device adverse event reports received","reports":218,"deaths":5,"injuries":4,"malfunctions":209,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2025 Q3: 218 adverse event reports received by the FDA (0 death, 12 injury, 206 malfunction and 0 other).","value":218,"unit":"device adverse event reports received","reports":218,"deaths":0,"injuries":12,"malfunctions":206,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stent, Carotid (product code NIM), 2025 Q3: 215 adverse event reports received by the FDA (14 death, 57 injury, 144 malfunction and 0 other).","value":215,"unit":"device adverse event reports received","reports":215,"deaths":14,"injuries":57,"malfunctions":144,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2025 Q3: 215 adverse event reports received by the FDA (0 death, 8 injury, 207 malfunction and 0 other).","value":215,"unit":"device adverse event reports received","reports":215,"deaths":0,"injuries":8,"malfunctions":207,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Device, Anti-Snoring (product code LRK), 2025 Q3: 213 adverse event reports received by the FDA (0 death, 20 injury, 193 malfunction and 0 other).","value":213,"unit":"device adverse event reports received","reports":213,"deaths":0,"injuries":20,"malfunctions":193,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2025 Q3: 213 adverse event reports received by the FDA (0 death, 90 injury, 123 malfunction and 0 other).","value":213,"unit":"device adverse event reports received","reports":213,"deaths":0,"injuries":90,"malfunctions":123,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2025 Q3: 212 adverse event reports received by the FDA (18 death, 97 injury, 97 malfunction and 0 other).","value":212,"unit":"device adverse event reports received","reports":212,"deaths":18,"injuries":97,"malfunctions":97,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GFD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Dermatome (product code GFD), 2025 Q3: 208 adverse event reports received by the FDA (0 death, 21 injury, 187 malfunction and 0 other).","value":208,"unit":"device adverse event reports received","reports":208,"deaths":0,"injuries":21,"malfunctions":187,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stretcher, Wheeled (product code FPO), 2025 Q3: 206 adverse event reports received by the FDA (0 death, 15 injury, 191 malfunction and 0 other).","value":206,"unit":"device adverse event reports received","reports":206,"deaths":0,"injuries":15,"malfunctions":191,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NSA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2025 Q3: 204 adverse event reports received by the FDA (1 death, 4 injury, 199 malfunction and 0 other).","value":204,"unit":"device adverse event reports received","reports":204,"deaths":1,"injuries":4,"malfunctions":199,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2025 Q3: 204 adverse event reports received by the FDA (0 death, 202 injury, 2 malfunction and 0 other).","value":204,"unit":"device adverse event reports received","reports":204,"deaths":0,"injuries":202,"malfunctions":2,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QHJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2025 Q3: 202 adverse event reports received by the FDA (0 death, 70 injury, 132 malfunction and 0 other).","value":202,"unit":"device adverse event reports received","reports":202,"deaths":0,"injuries":70,"malfunctions":132,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stent, Ureteral (product code FAD), 2025 Q3: 200 adverse event reports received by the FDA (0 death, 29 injury, 171 malfunction and 0 other).","value":200,"unit":"device adverse event reports received","reports":200,"deaths":0,"injuries":29,"malfunctions":171,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Septostomy (product code DXF), 2025 Q3: 199 adverse event reports received by the FDA (10 death, 109 injury, 80 malfunction and 0 other).","value":199,"unit":"device adverse event reports received","reports":199,"deaths":10,"injuries":109,"malfunctions":80,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PYX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2025 Q3: 198 adverse event reports received by the FDA (43 death, 55 injury, 100 malfunction and 0 other).","value":198,"unit":"device adverse event reports received","reports":198,"deaths":43,"injuries":55,"malfunctions":100,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2025 Q3: 196 adverse event reports received by the FDA (0 death, 12 injury, 184 malfunction and 0 other).","value":196,"unit":"device adverse event reports received","reports":196,"deaths":0,"injuries":12,"malfunctions":184,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MMI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2025 Q3: 194 adverse event reports received by the FDA (0 death, 18 injury, 176 malfunction and 0 other).","value":194,"unit":"device adverse event reports received","reports":194,"deaths":0,"injuries":18,"malfunctions":176,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QKP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2025 Q3: 190 adverse event reports received by the FDA (0 death, 1 injury, 189 malfunction and 0 other).","value":190,"unit":"device adverse event reports received","reports":190,"deaths":0,"injuries":1,"malfunctions":189,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2025 Q3: 184 adverse event reports received by the FDA (2 death, 12 injury, 170 malfunction and 0 other).","value":184,"unit":"device adverse event reports received","reports":184,"deaths":2,"injuries":12,"malfunctions":170,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2025 Q3: 183 adverse event reports received by the FDA (0 death, 54 injury, 129 malfunction and 0 other).","value":183,"unit":"device adverse event reports received","reports":183,"deaths":0,"injuries":54,"malfunctions":129,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2025 Q3: 182 adverse event reports received by the FDA (3 death, 7 injury, 172 malfunction and 0 other).","value":182,"unit":"device adverse event reports received","reports":182,"deaths":3,"injuries":7,"malfunctions":172,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2025 Q3: 181 adverse event reports received by the FDA (2 death, 61 injury, 118 malfunction and 0 other).","value":181,"unit":"device adverse event reports received","reports":181,"deaths":2,"injuries":61,"malfunctions":118,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2025 Q3: 180 adverse event reports received by the FDA (1 death, 44 injury, 135 malfunction and 0 other).","value":180,"unit":"device adverse event reports received","reports":180,"deaths":1,"injuries":44,"malfunctions":135,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2025 Q3: 179 adverse event reports received by the FDA (27 death, 55 injury, 96 malfunction and 1 other).","value":179,"unit":"device adverse event reports received","reports":179,"deaths":27,"injuries":55,"malfunctions":96,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JOH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2025 Q3: 179 adverse event reports received by the FDA (1 death, 14 injury, 164 malfunction and 0 other).","value":179,"unit":"device adverse event reports received","reports":179,"deaths":1,"injuries":14,"malfunctions":164,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2025 Q3: 178 adverse event reports received by the FDA (0 death, 14 injury, 164 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":0,"injuries":14,"malfunctions":164,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HNN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Knife, Ophthalmic (product code HNN), 2025 Q3: 178 adverse event reports received by the FDA (0 death, 8 injury, 170 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":0,"injuries":8,"malfunctions":170,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSD:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2025 Q3: 178 adverse event reports received by the FDA (0 death, 159 injury, 19 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":0,"injuries":159,"malfunctions":19,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2025 Q3: 178 adverse event reports received by the FDA (9 death, 23 injury, 146 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":9,"injuries":23,"malfunctions":146,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2025 Q3: 176 adverse event reports received by the FDA (35 death, 6 injury, 135 malfunction and 0 other).","value":176,"unit":"device adverse event reports received","reports":176,"deaths":35,"injuries":6,"malfunctions":135,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OBJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2025 Q3: 176 adverse event reports received by the FDA (2 death, 28 injury, 146 malfunction and 0 other).","value":176,"unit":"device adverse event reports received","reports":176,"deaths":2,"injuries":28,"malfunctions":146,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2025 Q3: 175 adverse event reports received by the FDA (0 death, 7 injury, 168 malfunction and 0 other).","value":175,"unit":"device adverse event reports received","reports":175,"deaths":0,"injuries":7,"malfunctions":168,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FCG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Biopsy Needle (product code FCG), 2025 Q3: 172 adverse event reports received by the FDA (0 death, 12 injury, 160 malfunction and 0 other).","value":172,"unit":"device adverse event reports received","reports":172,"deaths":0,"injuries":12,"malfunctions":160,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GIM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2025 Q3: 169 adverse event reports received by the FDA (0 death, 0 injury, 169 malfunction and 0 other).","value":169,"unit":"device adverse event reports received","reports":169,"deaths":0,"injuries":0,"malfunctions":169,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2025 Q3: 168 adverse event reports received by the FDA (3 death, 27 injury, 136 malfunction and 2 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":3,"injuries":27,"malfunctions":136,"other":2,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2025 Q3: 168 adverse event reports received by the FDA (0 death, 40 injury, 128 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":0,"injuries":40,"malfunctions":128,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GZF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2025 Q3: 168 adverse event reports received by the FDA (1 death, 167 injury, 0 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":1,"injuries":167,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2025 Q3: 166 adverse event reports received by the FDA (0 death, 10 injury, 156 malfunction and 0 other).","value":166,"unit":"device adverse event reports received","reports":166,"deaths":0,"injuries":10,"malfunctions":156,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Stent, Iliac (product code NIO), 2025 Q3: 165 adverse event reports received by the FDA (0 death, 56 injury, 109 malfunction and 0 other).","value":165,"unit":"device adverse event reports received","reports":165,"deaths":0,"injuries":56,"malfunctions":109,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LNH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2025 Q3: 161 adverse event reports received by the FDA (2 death, 39 injury, 119 malfunction and 1 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":2,"injuries":39,"malfunctions":119,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MTA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2025 Q3: 159 adverse event reports received by the FDA (0 death, 159 injury, 0 malfunction and 0 other).","value":159,"unit":"device adverse event reports received","reports":159,"deaths":0,"injuries":159,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2025 Q3: 157 adverse event reports received by the FDA (0 death, 7 injury, 150 malfunction and 0 other).","value":157,"unit":"device adverse event reports received","reports":157,"deaths":0,"injuries":7,"malfunctions":150,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HHS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2025 Q3: 156 adverse event reports received by the FDA (1 death, 155 injury, 0 malfunction and 0 other).","value":156,"unit":"device adverse event reports received","reports":156,"deaths":1,"injuries":155,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2025 Q3: 155 adverse event reports received by the FDA (0 death, 6 injury, 149 malfunction and 0 other).","value":155,"unit":"device adverse event reports received","reports":155,"deaths":0,"injuries":6,"malfunctions":149,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2025 Q3: 146 adverse event reports received by the FDA (0 death, 8 injury, 138 malfunction and 0 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":8,"malfunctions":138,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2025 Q3: 144 adverse event reports received by the FDA (0 death, 13 injury, 131 malfunction and 0 other).","value":144,"unit":"device adverse event reports received","reports":144,"deaths":0,"injuries":13,"malfunctions":131,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2025 Q3: 142 adverse event reports received by the FDA (0 death, 142 injury, 0 malfunction and 0 other).","value":142,"unit":"device adverse event reports received","reports":142,"deaths":0,"injuries":142,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2025 Q3: 141 adverse event reports received by the FDA (0 death, 139 injury, 2 malfunction and 0 other).","value":141,"unit":"device adverse event reports received","reports":141,"deaths":0,"injuries":139,"malfunctions":2,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Clamp, Vascular (product code DXC), 2025 Q3: 137 adverse event reports received by the FDA (0 death, 16 injury, 121 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":16,"malfunctions":121,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2025 Q3: 137 adverse event reports received by the FDA (0 death, 2 injury, 135 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":2,"malfunctions":135,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LCJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2025 Q3: 137 adverse event reports received by the FDA (0 death, 118 injury, 19 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":118,"malfunctions":19,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2025 Q3: 136 adverse event reports received by the FDA (2 death, 64 injury, 70 malfunction and 0 other).","value":136,"unit":"device adverse event reports received","reports":136,"deaths":2,"injuries":64,"malfunctions":70,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEQ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Toothbrush, Powered (product code JEQ), 2025 Q3: 136 adverse event reports received by the FDA (0 death, 1 injury, 135 malfunction and 0 other).","value":136,"unit":"device adverse event reports received","reports":136,"deaths":0,"injuries":1,"malfunctions":135,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MRM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2025 Q3: 136 adverse event reports received by the FDA (0 death, 40 injury, 95 malfunction and 1 other).","value":136,"unit":"device adverse event reports received","reports":136,"deaths":0,"injuries":40,"malfunctions":95,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2025 Q3: 135 adverse event reports received by the FDA (0 death, 99 injury, 36 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":0,"injuries":99,"malfunctions":36,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NRY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2025 Q3: 132 adverse event reports received by the FDA (8 death, 39 injury, 85 malfunction and 0 other).","value":132,"unit":"device adverse event reports received","reports":132,"deaths":8,"injuries":39,"malfunctions":85,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2025 Q3: 130 adverse event reports received by the FDA (0 death, 1 injury, 129 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":1,"malfunctions":129,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KTT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2025 Q3: 130 adverse event reports received by the FDA (0 death, 70 injury, 60 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":70,"malfunctions":60,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2025 Q3: 130 adverse event reports received by the FDA (0 death, 10 injury, 120 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":10,"malfunctions":120,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2025 Q3: 129 adverse event reports received by the FDA (0 death, 129 injury, 0 malfunction and 0 other).","value":129,"unit":"device adverse event reports received","reports":129,"deaths":0,"injuries":129,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2025 Q3: 125 adverse event reports received by the FDA (0 death, 36 injury, 89 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":36,"malfunctions":89,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KMY:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2025 Q3: 125 adverse event reports received by the FDA (0 death, 121 injury, 4 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":121,"malfunctions":4,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:POE:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2025 Q3: 124 adverse event reports received by the FDA (0 death, 75 injury, 49 malfunction and 0 other).","value":124,"unit":"device adverse event reports received","reports":124,"deaths":0,"injuries":75,"malfunctions":49,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2025 Q3: 123 adverse event reports received by the FDA (0 death, 4 injury, 119 malfunction and 0 other).","value":123,"unit":"device adverse event reports received","reports":123,"deaths":0,"injuries":4,"malfunctions":119,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Oximeter (product code DQA), 2025 Q3: 121 adverse event reports received by the FDA (6 death, 4 injury, 111 malfunction and 0 other).","value":121,"unit":"device adverse event reports received","reports":121,"deaths":6,"injuries":4,"malfunctions":111,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FSA:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2025 Q3: 120 adverse event reports received by the FDA (4 death, 38 injury, 78 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":4,"injuries":38,"malfunctions":78,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HEB:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2025 Q3: 120 adverse event reports received by the FDA (0 death, 3 injury, 117 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":0,"injuries":3,"malfunctions":117,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2025 Q3: 117 adverse event reports received by the FDA (1 death, 7 injury, 109 malfunction and 0 other).","value":117,"unit":"device adverse event reports received","reports":117,"deaths":1,"injuries":7,"malfunctions":109,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Urethroscope (product code FGC), 2025 Q3: 111 adverse event reports received by the FDA (0 death, 0 injury, 111 malfunction and 0 other).","value":111,"unit":"device adverse event reports received","reports":111,"deaths":0,"injuries":0,"malfunctions":111,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HCG:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2025 Q3: 111 adverse event reports received by the FDA (1 death, 19 injury, 91 malfunction and 0 other).","value":111,"unit":"device adverse event reports received","reports":111,"deaths":1,"injuries":19,"malfunctions":91,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PRL:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2025 Q3: 110 adverse event reports received by the FDA (3 death, 43 injury, 64 malfunction and 0 other).","value":110,"unit":"device adverse event reports received","reports":110,"deaths":3,"injuries":43,"malfunctions":64,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2025 Q3: 106 adverse event reports received by the FDA (0 death, 16 injury, 90 malfunction and 0 other).","value":106,"unit":"device adverse event reports received","reports":106,"deaths":0,"injuries":16,"malfunctions":90,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Endoscope, Rigid (product code GCM), 2025 Q3: 105 adverse event reports received by the FDA (0 death, 1 injury, 104 malfunction and 0 other).","value":105,"unit":"device adverse event reports received","reports":105,"deaths":0,"injuries":1,"malfunctions":104,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2025 Q3: 105 adverse event reports received by the FDA (0 death, 43 injury, 62 malfunction and 0 other).","value":105,"unit":"device adverse event reports received","reports":105,"deaths":0,"injuries":43,"malfunctions":62,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2025 Q3: 103 adverse event reports received by the FDA (3 death, 3 injury, 97 malfunction and 0 other).","value":103,"unit":"device adverse event reports received","reports":103,"deaths":3,"injuries":3,"malfunctions":97,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2025 Q3: 102 adverse event reports received by the FDA (0 death, 1 injury, 101 malfunction and 0 other).","value":102,"unit":"device adverse event reports received","reports":102,"deaths":0,"injuries":1,"malfunctions":101,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONU:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2025 Q3: 100 adverse event reports received by the FDA (0 death, 47 injury, 53 malfunction and 0 other).","value":100,"unit":"device adverse event reports received","reports":100,"deaths":0,"injuries":47,"malfunctions":53,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KGX:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2025 Q3: 97 adverse event reports received by the FDA (0 death, 81 injury, 15 malfunction and 1 other).","value":97,"unit":"device adverse event reports received","reports":97,"deaths":0,"injuries":81,"malfunctions":15,"other":1,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Wheelchair, Powered (product code ITI), 2025 Q3: 89 adverse event reports received by the FDA (0 death, 41 injury, 48 malfunction and 0 other).","value":89,"unit":"device adverse event reports received","reports":89,"deaths":0,"injuries":41,"malfunctions":48,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2025 Q3: 83 adverse event reports received by the FDA (5 death, 78 injury, 0 malfunction and 0 other).","value":83,"unit":"device adverse event reports received","reports":83,"deaths":5,"injuries":78,"malfunctions":0,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2025 Q3: 75 adverse event reports received by the FDA (0 death, 10 injury, 65 malfunction and 0 other).","value":75,"unit":"device adverse event reports received","reports":75,"deaths":0,"injuries":10,"malfunctions":65,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDC:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Calculator, Drug Dose (product code NDC), 2025 Q3: 75 adverse event reports received by the FDA (0 death, 0 injury, 75 malfunction and 0 other).","value":75,"unit":"device adverse event reports received","reports":75,"deaths":0,"injuries":0,"malfunctions":75,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCT:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2025 Q3: 74 adverse event reports received by the FDA (0 death, 0 injury, 74 malfunction and 0 other).","value":74,"unit":"device adverse event reports received","reports":74,"deaths":0,"injuries":0,"malfunctions":74,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQK:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2025 Q3: 71 adverse event reports received by the FDA (1 death, 11 injury, 59 malfunction and 0 other).","value":71,"unit":"device adverse event reports received","reports":71,"deaths":1,"injuries":11,"malfunctions":59,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OCW:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2025 Q3: 71 adverse event reports received by the FDA (0 death, 21 injury, 50 malfunction and 0 other).","value":71,"unit":"device adverse event reports received","reports":71,"deaths":0,"injuries":21,"malfunctions":50,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDP:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2025 Q3: 65 adverse event reports received by the FDA (0 death, 13 injury, 52 malfunction and 0 other).","value":65,"unit":"device adverse event reports received","reports":65,"deaths":0,"injuries":13,"malfunctions":52,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITJ:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Walker, Mechanical (product code ITJ), 2025 Q3: 57 adverse event reports received by the FDA (1 death, 44 injury, 12 malfunction and 0 other).","value":57,"unit":"device adverse event reports received","reports":57,"deaths":1,"injuries":44,"malfunctions":12,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXN:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2025 Q3: 53 adverse event reports received by the FDA (0 death, 4 injury, 49 malfunction and 0 other).","value":53,"unit":"device adverse event reports received","reports":53,"deaths":0,"injuries":4,"malfunctions":49,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Bariatric Bed (product code OSI), 2025 Q3: 42 adverse event reports received by the FDA (0 death, 4 injury, 38 malfunction and 0 other).","value":42,"unit":"device adverse event reports received","reports":42,"deaths":0,"injuries":4,"malfunctions":38,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAF:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2025 Q3: 37 adverse event reports received by the FDA (2 death, 7 injury, 28 malfunction and 0 other).","value":37,"unit":"device adverse event reports received","reports":37,"deaths":2,"injuries":7,"malfunctions":28,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2025 Q3: 36 adverse event reports received by the FDA (1 death, 8 injury, 27 malfunction and 0 other).","value":36,"unit":"device adverse event reports received","reports":36,"deaths":1,"injuries":8,"malfunctions":27,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IOR:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2025 Q3: 31 adverse event reports received by the FDA (0 death, 14 injury, 17 malfunction and 0 other).","value":31,"unit":"device adverse event reports received","reports":31,"deaths":0,"injuries":14,"malfunctions":17,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJH:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Orthopedic Tray (product code OJH), 2025 Q3: 31 adverse event reports received by the FDA (0 death, 15 injury, 16 malfunction and 0 other).","value":31,"unit":"device adverse event reports received","reports":31,"deaths":0,"injuries":15,"malfunctions":16,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Compressor, Air, Portable (product code BTI), 2025 Q3: 24 adverse event reports received by the FDA (0 death, 7 injury, 17 malfunction and 0 other).","value":24,"unit":"device adverse event reports received","reports":24,"deaths":0,"injuries":7,"malfunctions":17,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NQO:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NQO","deviceName":"Prosthesis, Spinous Process Spacer/Plate","specialty":"Unknown","deviceClass":"3","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Prosthesis, Spinous Process Spacer/Plate (product code NQO), 2025 Q3: 19 adverse event reports received by the FDA (0 death, 13 injury, 6 malfunction and 0 other).","value":19,"unit":"device adverse event reports received","reports":19,"deaths":0,"injuries":13,"malfunctions":6,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ILS:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Adaptor, Hygiene (product code ILS), 2025 Q3: 18 adverse event reports received by the FDA (0 death, 15 injury, 3 malfunction and 0 other).","value":18,"unit":"device adverse event reports received","reports":18,"deaths":0,"injuries":15,"malfunctions":3,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LLI:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LLI","deviceName":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (product code LLI), 2025 Q3: 11 adverse event reports received by the FDA (3 death, 5 injury, 3 malfunction and 0 other).","value":11,"unit":"device adverse event reports received","reports":11,"deaths":3,"injuries":5,"malfunctions":3,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:INM:2025Q3","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"INM","deviceName":"Chair, With Casters","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q3","year":2025,"qtr":3,"periodStart":"2025-07-01","periodEnd":"2025-09-30","status":"P","text":"Chair, With Casters (product code INM), 2025 Q3: 6 adverse event reports received by the FDA (2 death, 3 injury, 1 malfunction and 0 other).","value":6,"unit":"device adverse event reports received","reports":6,"deaths":2,"injuries":3,"malfunctions":1,"other":0,"effectiveFrom":"2025-07-01","effectiveTo":"2025-09-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DZE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2025 Q2: 121,974 adverse event reports received by the FDA (0 death, 121,793 injury, 181 malfunction and 0 other).","value":121974,"unit":"device adverse event reports received","reports":121974,"deaths":0,"injuries":121793,"malfunctions":181,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2025 Q2: 97,575 adverse event reports received by the FDA (7 death, 2,663 injury, 94,900 malfunction and 5 other).","value":97575,"unit":"device adverse event reports received","reports":97575,"deaths":7,"injuries":2663,"malfunctions":94900,"other":5,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QFG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2025 Q2: 70,296 adverse event reports received by the FDA (17 death, 8,308 injury, 61,970 malfunction and 1 other).","value":70296,"unit":"device adverse event reports received","reports":70296,"deaths":17,"injuries":8308,"malfunctions":61970,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2025 Q2: 37,407 adverse event reports received by the FDA (42 death, 4,217 injury, 33,148 malfunction and 0 other).","value":37407,"unit":"device adverse event reports received","reports":37407,"deaths":42,"injuries":4217,"malfunctions":33148,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2025 Q2: 15,689 adverse event reports received by the FDA (25 death, 502 injury, 15,160 malfunction and 2 other).","value":15689,"unit":"device adverse event reports received","reports":15689,"deaths":25,"injuries":502,"malfunctions":15160,"other":2,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BRY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2025 Q2: 13,919 adverse event reports received by the FDA (2 death, 4 injury, 13,913 malfunction and 0 other).","value":13919,"unit":"device adverse event reports received","reports":13919,"deaths":2,"injuries":4,"malfunctions":13913,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FRN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pump, Infusion (product code FRN), 2025 Q2: 13,046 adverse event reports received by the FDA (28 death, 195 injury, 12,819 malfunction and 4 other).","value":13046,"unit":"device adverse event reports received","reports":13046,"deaths":28,"injuries":195,"malfunctions":12819,"other":4,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2025 Q2: 10,395 adverse event reports received by the FDA (3 death, 1,742 injury, 8,650 malfunction and 0 other).","value":10395,"unit":"device adverse event reports received","reports":10395,"deaths":3,"injuries":1742,"malfunctions":8650,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PQF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2025 Q2: 9,176 adverse event reports received by the FDA (0 death, 45 injury, 9,131 malfunction and 0 other).","value":9176,"unit":"device adverse event reports received","reports":9176,"deaths":0,"injuries":45,"malfunctions":9131,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LGW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2025 Q2: 8,154 adverse event reports received by the FDA (6 death, 6,535 injury, 1,613 malfunction and 0 other).","value":8154,"unit":"device adverse event reports received","reports":8154,"deaths":6,"injuries":6535,"malfunctions":1613,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BZD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2025 Q2: 7,809 adverse event reports received by the FDA (180 death, 801 injury, 6,827 malfunction and 1 other).","value":7809,"unit":"device adverse event reports received","reports":7809,"deaths":180,"injuries":801,"malfunctions":6827,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2025 Q2: 7,756 adverse event reports received by the FDA (0 death, 7,634 injury, 122 malfunction and 0 other).","value":7756,"unit":"device adverse event reports received","reports":7756,"deaths":0,"injuries":7634,"malfunctions":122,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2025 Q2: 6,628 adverse event reports received by the FDA (71 death, 2,846 injury, 3,711 malfunction and 0 other).","value":6628,"unit":"device adverse event reports received","reports":6628,"deaths":71,"injuries":2846,"malfunctions":3711,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QLG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2025 Q2: 6,126 adverse event reports received by the FDA (1 death, 861 injury, 5,264 malfunction and 0 other).","value":6126,"unit":"device adverse event reports received","reports":6126,"deaths":1,"injuries":861,"malfunctions":5264,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2025 Q2: 5,997 adverse event reports received by the FDA (68 death, 3,424 injury, 2,505 malfunction and 0 other).","value":5997,"unit":"device adverse event reports received","reports":5997,"deaths":68,"injuries":3424,"malfunctions":2505,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2025 Q2: 5,878 adverse event reports received by the FDA (98 death, 3,272 injury, 2,508 malfunction and 0 other).","value":5878,"unit":"device adverse event reports received","reports":5878,"deaths":98,"injuries":3272,"malfunctions":2508,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CBK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2025 Q2: 3,730 adverse event reports received by the FDA (23 death, 55 injury, 3,652 malfunction and 0 other).","value":3730,"unit":"device adverse event reports received","reports":3730,"deaths":23,"injuries":55,"malfunctions":3652,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2025 Q2: 3,567 adverse event reports received by the FDA (331 death, 2,144 injury, 1,092 malfunction and 0 other).","value":3567,"unit":"device adverse event reports received","reports":3567,"deaths":331,"injuries":2144,"malfunctions":1092,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MGB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2025 Q2: 3,560 adverse event reports received by the FDA (12 death, 2,751 injury, 795 malfunction and 2 other).","value":3560,"unit":"device adverse event reports received","reports":3560,"deaths":12,"injuries":2751,"malfunctions":795,"other":2,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2025 Q2: 3,348 adverse event reports received by the FDA (2 death, 30 injury, 3,316 malfunction and 0 other).","value":3348,"unit":"device adverse event reports received","reports":3348,"deaths":2,"injuries":30,"malfunctions":3316,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OYC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2025 Q2: 3,102 adverse event reports received by the FDA (2 death, 22 injury, 3,078 malfunction and 0 other).","value":3102,"unit":"device adverse event reports received","reports":3102,"deaths":2,"injuries":22,"malfunctions":3078,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2025 Q2: 3,079 adverse event reports received by the FDA (0 death, 31 injury, 3,048 malfunction and 0 other).","value":3079,"unit":"device adverse event reports received","reports":3079,"deaths":0,"injuries":31,"malfunctions":3048,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MKJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2025 Q2: 3,077 adverse event reports received by the FDA (30 death, 44 injury, 3,003 malfunction and 0 other).","value":3077,"unit":"device adverse event reports received","reports":3077,"deaths":30,"injuries":44,"malfunctions":3003,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BSZ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2025 Q2: 2,963 adverse event reports received by the FDA (0 death, 21 injury, 2,942 malfunction and 0 other).","value":2963,"unit":"device adverse event reports received","reports":2963,"deaths":0,"injuries":21,"malfunctions":2942,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Staple, Implantable (product code GDW), 2025 Q2: 2,921 adverse event reports received by the FDA (17 death, 345 injury, 2,559 malfunction and 0 other).","value":2921,"unit":"device adverse event reports received","reports":2921,"deaths":17,"injuries":345,"malfunctions":2559,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MVK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2025 Q2: 2,907 adverse event reports received by the FDA (65 death, 890 injury, 1,952 malfunction and 0 other).","value":2907,"unit":"device adverse event reports received","reports":2907,"deaths":65,"injuries":890,"malfunctions":1952,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FET:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2025 Q2: 2,888 adverse event reports received by the FDA (0 death, 7 injury, 2,881 malfunction and 0 other).","value":2888,"unit":"device adverse event reports received","reports":2888,"deaths":0,"injuries":7,"malfunctions":2881,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2025 Q2: 2,845 adverse event reports received by the FDA (44 death, 1,094 injury, 1,707 malfunction and 0 other).","value":2845,"unit":"device adverse event reports received","reports":2845,"deaths":44,"injuries":1094,"malfunctions":1707,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OWB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2025 Q2: 2,810 adverse event reports received by the FDA (5 death, 12 injury, 2,793 malfunction and 0 other).","value":2810,"unit":"device adverse event reports received","reports":2810,"deaths":5,"injuries":12,"malfunctions":2793,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2025 Q2: 2,798 adverse event reports received by the FDA (1 death, 162 injury, 2,635 malfunction and 0 other).","value":2798,"unit":"device adverse event reports received","reports":2798,"deaths":1,"injuries":162,"malfunctions":2635,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSQ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2025 Q2: 2,751 adverse event reports received by the FDA (529 death, 972 injury, 1,250 malfunction and 0 other).","value":2751,"unit":"device adverse event reports received","reports":2751,"deaths":529,"injuries":972,"malfunctions":1250,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2025 Q2: 2,674 adverse event reports received by the FDA (34 death, 1,407 injury, 1,233 malfunction and 0 other).","value":2674,"unit":"device adverse event reports received","reports":2674,"deaths":34,"injuries":1407,"malfunctions":1233,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2025 Q2: 2,652 adverse event reports received by the FDA (464 death, 1,215 injury, 973 malfunction and 0 other).","value":2652,"unit":"device adverse event reports received","reports":2652,"deaths":464,"injuries":1215,"malfunctions":973,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2025 Q2: 2,639 adverse event reports received by the FDA (28 death, 1,391 injury, 1,217 malfunction and 3 other).","value":2639,"unit":"device adverse event reports received","reports":2639,"deaths":28,"injuries":1391,"malfunctions":1217,"other":3,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2025 Q2: 2,418 adverse event reports received by the FDA (5 death, 525 injury, 1,888 malfunction and 0 other).","value":2418,"unit":"device adverse event reports received","reports":2418,"deaths":5,"injuries":525,"malfunctions":1888,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKU:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2025 Q2: 2,414 adverse event reports received by the FDA (0 death, 2 injury, 2,412 malfunction and 0 other).","value":2414,"unit":"device adverse event reports received","reports":2414,"deaths":0,"injuries":2,"malfunctions":2412,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JWH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2025 Q2: 2,356 adverse event reports received by the FDA (0 death, 2,131 injury, 225 malfunction and 0 other).","value":2356,"unit":"device adverse event reports received","reports":2356,"deaths":0,"injuries":2131,"malfunctions":225,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FWM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2025 Q2: 2,305 adverse event reports received by the FDA (0 death, 2,285 injury, 20 malfunction and 0 other).","value":2305,"unit":"device adverse event reports received","reports":2305,"deaths":0,"injuries":2285,"malfunctions":20,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2025 Q2: 1,901 adverse event reports received by the FDA (8 death, 300 injury, 1,593 malfunction and 0 other).","value":1901,"unit":"device adverse event reports received","reports":1901,"deaths":8,"injuries":300,"malfunctions":1593,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2025 Q2: 1,873 adverse event reports received by the FDA (0 death, 912 injury, 961 malfunction and 0 other).","value":1873,"unit":"device adverse event reports received","reports":1873,"deaths":0,"injuries":912,"malfunctions":961,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2025 Q2: 1,702 adverse event reports received by the FDA (8 death, 18 injury, 1,676 malfunction and 0 other).","value":1702,"unit":"device adverse event reports received","reports":1702,"deaths":8,"injuries":18,"malfunctions":1676,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVZ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2025 Q2: 1,620 adverse event reports received by the FDA (52 death, 847 injury, 720 malfunction and 1 other).","value":1620,"unit":"device adverse event reports received","reports":1620,"deaths":52,"injuries":847,"malfunctions":720,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2025 Q2: 1,585 adverse event reports received by the FDA (2 death, 1,383 injury, 200 malfunction and 0 other).","value":1585,"unit":"device adverse event reports received","reports":1585,"deaths":2,"injuries":1383,"malfunctions":200,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2025 Q2: 1,493 adverse event reports received by the FDA (1 death, 95 injury, 1,397 malfunction and 0 other).","value":1493,"unit":"device adverse event reports received","reports":1493,"deaths":1,"injuries":95,"malfunctions":1397,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2025 Q2: 1,493 adverse event reports received by the FDA (2 death, 44 injury, 1,447 malfunction and 0 other).","value":1493,"unit":"device adverse event reports received","reports":1493,"deaths":2,"injuries":44,"malfunctions":1447,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LKK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2025 Q2: 1,483 adverse event reports received by the FDA (3 death, 682 injury, 797 malfunction and 1 other).","value":1483,"unit":"device adverse event reports received","reports":1483,"deaths":3,"injuries":682,"malfunctions":797,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Intraocular Lens (product code HQL), 2025 Q2: 1,435 adverse event reports received by the FDA (0 death, 306 injury, 1,128 malfunction and 1 other).","value":1435,"unit":"device adverse event reports received","reports":1435,"deaths":0,"injuries":306,"malfunctions":1128,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Implant, Cochlear (product code MCM), 2025 Q2: 1,399 adverse event reports received by the FDA (1 death, 864 injury, 534 malfunction and 0 other).","value":1399,"unit":"device adverse event reports received","reports":1399,"deaths":1,"injuries":864,"malfunctions":534,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FOZ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2025 Q2: 1,383 adverse event reports received by the FDA (1 death, 92 injury, 1,290 malfunction and 0 other).","value":1383,"unit":"device adverse event reports received","reports":1383,"deaths":1,"injuries":92,"malfunctions":1290,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JKA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2025 Q2: 1,380 adverse event reports received by the FDA (0 death, 12 injury, 1,368 malfunction and 0 other).","value":1380,"unit":"device adverse event reports received","reports":1380,"deaths":0,"injuries":12,"malfunctions":1368,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOQ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2025 Q2: 1,324 adverse event reports received by the FDA (10 death, 116 injury, 1,198 malfunction and 0 other).","value":1324,"unit":"device adverse event reports received","reports":1324,"deaths":10,"injuries":116,"malfunctions":1198,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Steerable (product code DRA), 2025 Q2: 1,245 adverse event reports received by the FDA (11 death, 242 injury, 992 malfunction and 0 other).","value":1245,"unit":"device adverse event reports received","reports":1245,"deaths":11,"injuries":242,"malfunctions":992,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2025 Q2: 1,211 adverse event reports received by the FDA (0 death, 32 injury, 1,179 malfunction and 0 other).","value":1211,"unit":"device adverse event reports received","reports":1211,"deaths":0,"injuries":32,"malfunctions":1179,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2025 Q2: 1,177 adverse event reports received by the FDA (11 death, 183 injury, 983 malfunction and 0 other).","value":1177,"unit":"device adverse event reports received","reports":1177,"deaths":11,"injuries":183,"malfunctions":983,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2025 Q2: 1,162 adverse event reports received by the FDA (1 death, 69 injury, 1,092 malfunction and 0 other).","value":1162,"unit":"device adverse event reports received","reports":1162,"deaths":1,"injuries":69,"malfunctions":1092,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Syringe, Piston (product code FMF), 2025 Q2: 1,159 adverse event reports received by the FDA (0 death, 102 injury, 1,057 malfunction and 0 other).","value":1159,"unit":"device adverse event reports received","reports":1159,"deaths":0,"injuries":102,"malfunctions":1057,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"General Surgery Tray (product code LRO), 2025 Q2: 1,156 adverse event reports received by the FDA (0 death, 50 injury, 1,106 malfunction and 0 other).","value":1156,"unit":"device adverse event reports received","reports":1156,"deaths":0,"injuries":50,"malfunctions":1106,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2025 Q2: 1,114 adverse event reports received by the FDA (6 death, 1,041 injury, 67 malfunction and 0 other).","value":1114,"unit":"device adverse event reports received","reports":1114,"deaths":6,"injuries":1041,"malfunctions":67,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JJE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2025 Q2: 1,090 adverse event reports received by the FDA (0 death, 23 injury, 1,067 malfunction and 0 other).","value":1090,"unit":"device adverse event reports received","reports":1090,"deaths":0,"injuries":23,"malfunctions":1067,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Introducer, Catheter (product code DYB), 2025 Q2: 1,082 adverse event reports received by the FDA (51 death, 242 injury, 789 malfunction and 0 other).","value":1082,"unit":"device adverse event reports received","reports":1082,"deaths":51,"injuries":242,"malfunctions":789,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Leadless Pacemaker (product code PNJ), 2025 Q2: 1,077 adverse event reports received by the FDA (75 death, 415 injury, 587 malfunction and 0 other).","value":1077,"unit":"device adverse event reports received","reports":1077,"deaths":75,"injuries":415,"malfunctions":587,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2025 Q2: 1,039 adverse event reports received by the FDA (0 death, 58 injury, 981 malfunction and 0 other).","value":1039,"unit":"device adverse event reports received","reports":1039,"deaths":0,"injuries":58,"malfunctions":981,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2025 Q2: 1,038 adverse event reports received by the FDA (1 death, 113 injury, 924 malfunction and 0 other).","value":1038,"unit":"device adverse event reports received","reports":1038,"deaths":1,"injuries":113,"malfunctions":924,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NXC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Aligner, Sequential (product code NXC), 2025 Q2: 1,000 adverse event reports received by the FDA (0 death, 970 injury, 30 malfunction and 0 other).","value":1000,"unit":"device adverse event reports received","reports":1000,"deaths":0,"injuries":970,"malfunctions":30,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QZI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2025 Q2: 1,000 adverse event reports received by the FDA (29 death, 420 injury, 551 malfunction and 0 other).","value":1000,"unit":"device adverse event reports received","reports":1000,"deaths":29,"injuries":420,"malfunctions":551,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2025 Q2: 974 adverse event reports received by the FDA (1 death, 32 injury, 941 malfunction and 0 other).","value":974,"unit":"device adverse event reports received","reports":974,"deaths":1,"injuries":32,"malfunctions":941,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2025 Q2: 971 adverse event reports received by the FDA (0 death, 5 injury, 966 malfunction and 0 other).","value":971,"unit":"device adverse event reports received","reports":971,"deaths":0,"injuries":5,"malfunctions":966,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2025 Q2: 960 adverse event reports received by the FDA (2 death, 790 injury, 168 malfunction and 0 other).","value":960,"unit":"device adverse event reports received","reports":960,"deaths":2,"injuries":790,"malfunctions":168,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HET:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2025 Q2: 930 adverse event reports received by the FDA (0 death, 3 injury, 927 malfunction and 0 other).","value":930,"unit":"device adverse event reports received","reports":930,"deaths":0,"injuries":3,"malfunctions":927,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2025 Q2: 912 adverse event reports received by the FDA (11 death, 647 injury, 254 malfunction and 0 other).","value":912,"unit":"device adverse event reports received","reports":912,"deaths":11,"injuries":647,"malfunctions":254,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Replacement Heart-Valve (product code DYE), 2025 Q2: 911 adverse event reports received by the FDA (6 death, 880 injury, 25 malfunction and 0 other).","value":911,"unit":"device adverse event reports received","reports":911,"deaths":6,"injuries":880,"malfunctions":25,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2025 Q2: 898 adverse event reports received by the FDA (1 death, 57 injury, 840 malfunction and 0 other).","value":898,"unit":"device adverse event reports received","reports":898,"deaths":1,"injuries":57,"malfunctions":840,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MIH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2025 Q2: 879 adverse event reports received by the FDA (71 death, 626 injury, 182 malfunction and 0 other).","value":879,"unit":"device adverse event reports received","reports":879,"deaths":71,"injuries":626,"malfunctions":182,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2025 Q2: 835 adverse event reports received by the FDA (22 death, 182 injury, 631 malfunction and 0 other).","value":835,"unit":"device adverse event reports received","reports":835,"deaths":22,"injuries":182,"malfunctions":631,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2025 Q2: 829 adverse event reports received by the FDA (0 death, 413 injury, 416 malfunction and 0 other).","value":829,"unit":"device adverse event reports received","reports":829,"deaths":0,"injuries":413,"malfunctions":416,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Percutaneous (product code DQY), 2025 Q2: 822 adverse event reports received by the FDA (21 death, 207 injury, 594 malfunction and 0 other).","value":822,"unit":"device adverse event reports received","reports":822,"deaths":21,"injuries":207,"malfunctions":594,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2025 Q2: 816 adverse event reports received by the FDA (4 death, 1 injury, 810 malfunction and 1 other).","value":816,"unit":"device adverse event reports received","reports":816,"deaths":4,"injuries":1,"malfunctions":810,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2025 Q2: 814 adverse event reports received by the FDA (10 death, 450 injury, 354 malfunction and 0 other).","value":814,"unit":"device adverse event reports received","reports":814,"deaths":10,"injuries":450,"malfunctions":354,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2025 Q2: 813 adverse event reports received by the FDA (0 death, 8 injury, 805 malfunction and 0 other).","value":813,"unit":"device adverse event reports received","reports":813,"deaths":0,"injuries":8,"malfunctions":805,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FKX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2025 Q2: 801 adverse event reports received by the FDA (23 death, 291 injury, 487 malfunction and 0 other).","value":801,"unit":"device adverse event reports received","reports":801,"deaths":23,"injuries":291,"malfunctions":487,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PHX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2025 Q2: 789 adverse event reports received by the FDA (0 death, 696 injury, 93 malfunction and 0 other).","value":789,"unit":"device adverse event reports received","reports":789,"deaths":0,"injuries":696,"malfunctions":93,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2025 Q2: 775 adverse event reports received by the FDA (1 death, 68 injury, 706 malfunction and 0 other).","value":775,"unit":"device adverse event reports received","reports":775,"deaths":1,"injuries":68,"malfunctions":706,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NEW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2025 Q2: 769 adverse event reports received by the FDA (0 death, 188 injury, 581 malfunction and 0 other).","value":769,"unit":"device adverse event reports received","reports":769,"deaths":0,"injuries":188,"malfunctions":581,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2025 Q2: 757 adverse event reports received by the FDA (0 death, 98 injury, 659 malfunction and 0 other).","value":757,"unit":"device adverse event reports received","reports":757,"deaths":0,"injuries":98,"malfunctions":659,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2025 Q2: 755 adverse event reports received by the FDA (0 death, 371 injury, 384 malfunction and 0 other).","value":755,"unit":"device adverse event reports received","reports":755,"deaths":0,"injuries":371,"malfunctions":384,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2025 Q2: 732 adverse event reports received by the FDA (1 death, 180 injury, 549 malfunction and 2 other).","value":732,"unit":"device adverse event reports received","reports":732,"deaths":1,"injuries":180,"malfunctions":549,"other":2,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2025 Q2: 717 adverse event reports received by the FDA (4 death, 47 injury, 665 malfunction and 1 other).","value":717,"unit":"device adverse event reports received","reports":717,"deaths":4,"injuries":47,"malfunctions":665,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2025 Q2: 693 adverse event reports received by the FDA (5 death, 198 injury, 490 malfunction and 0 other).","value":693,"unit":"device adverse event reports received","reports":693,"deaths":5,"injuries":198,"malfunctions":490,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OLO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2025 Q2: 693 adverse event reports received by the FDA (0 death, 81 injury, 612 malfunction and 0 other).","value":693,"unit":"device adverse event reports received","reports":693,"deaths":0,"injuries":81,"malfunctions":612,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FHW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2025 Q2: 683 adverse event reports received by the FDA (0 death, 628 injury, 55 malfunction and 0 other).","value":683,"unit":"device adverse event reports received","reports":683,"deaths":0,"injuries":628,"malfunctions":55,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2025 Q2: 681 adverse event reports received by the FDA (26 death, 399 injury, 256 malfunction and 0 other).","value":681,"unit":"device adverse event reports received","reports":681,"deaths":26,"injuries":399,"malfunctions":256,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MOM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2025 Q2: 677 adverse event reports received by the FDA (2 death, 148 injury, 527 malfunction and 0 other).","value":677,"unit":"device adverse event reports received","reports":677,"deaths":2,"injuries":148,"malfunctions":527,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2025 Q2: 673 adverse event reports received by the FDA (1 death, 23 injury, 649 malfunction and 0 other).","value":673,"unit":"device adverse event reports received","reports":673,"deaths":1,"injuries":23,"malfunctions":649,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2025 Q2: 670 adverse event reports received by the FDA (0 death, 8 injury, 662 malfunction and 0 other).","value":670,"unit":"device adverse event reports received","reports":670,"deaths":0,"injuries":8,"malfunctions":662,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2025 Q2: 654 adverse event reports received by the FDA (2 death, 74 injury, 578 malfunction and 0 other).","value":654,"unit":"device adverse event reports received","reports":654,"deaths":2,"injuries":74,"malfunctions":578,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Thermal Regulating (product code DWJ), 2025 Q2: 615 adverse event reports received by the FDA (0 death, 18 injury, 597 malfunction and 0 other).","value":615,"unit":"device adverse event reports received","reports":615,"deaths":0,"injuries":18,"malfunctions":597,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2025 Q2: 612 adverse event reports received by the FDA (0 death, 1 injury, 611 malfunction and 0 other).","value":612,"unit":"device adverse event reports received","reports":612,"deaths":0,"injuries":1,"malfunctions":611,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2025 Q2: 606 adverse event reports received by the FDA (0 death, 549 injury, 57 malfunction and 0 other).","value":606,"unit":"device adverse event reports received","reports":606,"deaths":0,"injuries":549,"malfunctions":57,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2025 Q2: 605 adverse event reports received by the FDA (0 death, 193 injury, 412 malfunction and 0 other).","value":605,"unit":"device adverse event reports received","reports":605,"deaths":0,"injuries":193,"malfunctions":412,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2025 Q2: 603 adverse event reports received by the FDA (4 death, 328 injury, 271 malfunction and 0 other).","value":603,"unit":"device adverse event reports received","reports":603,"deaths":4,"injuries":328,"malfunctions":271,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Template (product code HWT), 2025 Q2: 601 adverse event reports received by the FDA (0 death, 5 injury, 596 malfunction and 0 other).","value":601,"unit":"device adverse event reports received","reports":601,"deaths":0,"injuries":5,"malfunctions":596,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2025 Q2: 601 adverse event reports received by the FDA (4 death, 63 injury, 534 malfunction and 0 other).","value":601,"unit":"device adverse event reports received","reports":601,"deaths":4,"injuries":63,"malfunctions":534,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2025 Q2: 599 adverse event reports received by the FDA (1 death, 9 injury, 589 malfunction and 0 other).","value":599,"unit":"device adverse event reports received","reports":599,"deaths":1,"injuries":9,"malfunctions":589,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LOX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2025 Q2: 597 adverse event reports received by the FDA (31 death, 258 injury, 308 malfunction and 0 other).","value":597,"unit":"device adverse event reports received","reports":597,"deaths":31,"injuries":258,"malfunctions":308,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIQ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2025 Q2: 593 adverse event reports received by the FDA (32 death, 309 injury, 252 malfunction and 0 other).","value":593,"unit":"device adverse event reports received","reports":593,"deaths":32,"injuries":309,"malfunctions":252,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2025 Q2: 586 adverse event reports received by the FDA (0 death, 2 injury, 584 malfunction and 0 other).","value":586,"unit":"device adverse event reports received","reports":586,"deaths":0,"injuries":2,"malfunctions":584,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NGV:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2025 Q2: 564 adverse event reports received by the FDA (47 death, 479 injury, 38 malfunction and 0 other).","value":564,"unit":"device adverse event reports received","reports":564,"deaths":47,"injuries":479,"malfunctions":38,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2025 Q2: 560 adverse event reports received by the FDA (18 death, 213 injury, 329 malfunction and 0 other).","value":560,"unit":"device adverse event reports received","reports":560,"deaths":18,"injuries":213,"malfunctions":329,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2025 Q2: 559 adverse event reports received by the FDA (3 death, 399 injury, 157 malfunction and 0 other).","value":559,"unit":"device adverse event reports received","reports":559,"deaths":3,"injuries":399,"malfunctions":157,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2025 Q2: 529 adverse event reports received by the FDA (2 death, 60 injury, 467 malfunction and 0 other).","value":529,"unit":"device adverse event reports received","reports":529,"deaths":2,"injuries":60,"malfunctions":467,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Arthroscope (product code HRX), 2025 Q2: 522 adverse event reports received by the FDA (0 death, 20 injury, 502 malfunction and 0 other).","value":522,"unit":"device adverse event reports received","reports":522,"deaths":0,"injuries":20,"malfunctions":502,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2025 Q2: 520 adverse event reports received by the FDA (0 death, 19 injury, 501 malfunction and 0 other).","value":520,"unit":"device adverse event reports received","reports":520,"deaths":0,"injuries":19,"malfunctions":501,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Impactor (product code HWA), 2025 Q2: 519 adverse event reports received by the FDA (0 death, 1 injury, 518 malfunction and 0 other).","value":519,"unit":"device adverse event reports received","reports":519,"deaths":0,"injuries":1,"malfunctions":518,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2025 Q2: 514 adverse event reports received by the FDA (0 death, 504 injury, 10 malfunction and 0 other).","value":514,"unit":"device adverse event reports received","reports":514,"deaths":0,"injuries":504,"malfunctions":10,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2025 Q2: 514 adverse event reports received by the FDA (0 death, 125 injury, 389 malfunction and 0 other).","value":514,"unit":"device adverse event reports received","reports":514,"deaths":0,"injuries":125,"malfunctions":389,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PMP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2025 Q2: 504 adverse event reports received by the FDA (0 death, 495 injury, 9 malfunction and 0 other).","value":504,"unit":"device adverse event reports received","reports":504,"deaths":0,"injuries":495,"malfunctions":9,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Clip, Implantable (product code FZP), 2025 Q2: 500 adverse event reports received by the FDA (1 death, 22 injury, 477 malfunction and 0 other).","value":500,"unit":"device adverse event reports received","reports":500,"deaths":1,"injuries":22,"malfunctions":477,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IZI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2025 Q2: 499 adverse event reports received by the FDA (0 death, 4 injury, 494 malfunction and 1 other).","value":499,"unit":"device adverse event reports received","reports":499,"deaths":0,"injuries":4,"malfunctions":494,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2025 Q2: 495 adverse event reports received by the FDA (2 death, 38 injury, 454 malfunction and 1 other).","value":495,"unit":"device adverse event reports received","reports":495,"deaths":2,"injuries":38,"malfunctions":454,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LIT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2025 Q2: 493 adverse event reports received by the FDA (0 death, 65 injury, 428 malfunction and 0 other).","value":493,"unit":"device adverse event reports received","reports":493,"deaths":0,"injuries":65,"malfunctions":428,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HXX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Screwdriver (product code HXX), 2025 Q2: 479 adverse event reports received by the FDA (0 death, 11 injury, 468 malfunction and 0 other).","value":479,"unit":"device adverse event reports received","reports":479,"deaths":0,"injuries":11,"malfunctions":468,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2025 Q2: 477 adverse event reports received by the FDA (3 death, 79 injury, 395 malfunction and 0 other).","value":477,"unit":"device adverse event reports received","reports":477,"deaths":3,"injuries":79,"malfunctions":395,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2025 Q2: 453 adverse event reports received by the FDA (0 death, 8 injury, 445 malfunction and 0 other).","value":453,"unit":"device adverse event reports received","reports":453,"deaths":0,"injuries":8,"malfunctions":445,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SAF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2025 Q2: 446 adverse event reports received by the FDA (0 death, 28 injury, 418 malfunction and 0 other).","value":446,"unit":"device adverse event reports received","reports":446,"deaths":0,"injuries":28,"malfunctions":418,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JCW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2025 Q2: 445 adverse event reports received by the FDA (0 death, 419 injury, 26 malfunction and 0 other).","value":445,"unit":"device adverse event reports received","reports":445,"deaths":0,"injuries":419,"malfunctions":26,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2025 Q2: 443 adverse event reports received by the FDA (16 death, 381 injury, 46 malfunction and 0 other).","value":443,"unit":"device adverse event reports received","reports":443,"deaths":16,"injuries":381,"malfunctions":46,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTC","deviceName":"Analyzer, Pacemaker Generator Function","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Analyzer, Pacemaker Generator Function (product code DTC), 2025 Q2: 430 adverse event reports received by the FDA (0 death, 8 injury, 422 malfunction and 0 other).","value":430,"unit":"device adverse event reports received","reports":430,"deaths":0,"injuries":8,"malfunctions":422,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LMH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2025 Q2: 424 adverse event reports received by the FDA (1 death, 420 injury, 3 malfunction and 0 other).","value":424,"unit":"device adverse event reports received","reports":424,"deaths":1,"injuries":420,"malfunctions":3,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ERL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2025 Q2: 408 adverse event reports received by the FDA (0 death, 3 injury, 405 malfunction and 0 other).","value":408,"unit":"device adverse event reports received","reports":408,"deaths":0,"injuries":3,"malfunctions":405,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2025 Q2: 407 adverse event reports received by the FDA (4 death, 71 injury, 332 malfunction and 0 other).","value":407,"unit":"device adverse event reports received","reports":407,"deaths":4,"injuries":71,"malfunctions":332,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Bit, Drill (product code HTW), 2025 Q2: 405 adverse event reports received by the FDA (0 death, 16 injury, 389 malfunction and 0 other).","value":405,"unit":"device adverse event reports received","reports":405,"deaths":0,"injuries":16,"malfunctions":389,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2025 Q2: 400 adverse event reports received by the FDA (9 death, 221 injury, 170 malfunction and 0 other).","value":400,"unit":"device adverse event reports received","reports":400,"deaths":9,"injuries":221,"malfunctions":170,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2025 Q2: 396 adverse event reports received by the FDA (0 death, 84 injury, 312 malfunction and 0 other).","value":396,"unit":"device adverse event reports received","reports":396,"deaths":0,"injuries":84,"malfunctions":312,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2025 Q2: 391 adverse event reports received by the FDA (4 death, 187 injury, 200 malfunction and 0 other).","value":391,"unit":"device adverse event reports received","reports":391,"deaths":4,"injuries":187,"malfunctions":200,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2025 Q2: 391 adverse event reports received by the FDA (0 death, 316 injury, 75 malfunction and 0 other).","value":391,"unit":"device adverse event reports received","reports":391,"deaths":0,"injuries":316,"malfunctions":75,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2025 Q2: 388 adverse event reports received by the FDA (0 death, 51 injury, 337 malfunction and 0 other).","value":388,"unit":"device adverse event reports received","reports":388,"deaths":0,"injuries":51,"malfunctions":337,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2025 Q2: 388 adverse event reports received by the FDA (1 death, 75 injury, 312 malfunction and 0 other).","value":388,"unit":"device adverse event reports received","reports":388,"deaths":1,"injuries":75,"malfunctions":312,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LYJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2025 Q2: 388 adverse event reports received by the FDA (26 death, 149 injury, 213 malfunction and 0 other).","value":388,"unit":"device adverse event reports received","reports":388,"deaths":26,"injuries":149,"malfunctions":213,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2025 Q2: 386 adverse event reports received by the FDA (0 death, 1 injury, 385 malfunction and 0 other).","value":386,"unit":"device adverse event reports received","reports":386,"deaths":0,"injuries":1,"malfunctions":385,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JDI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2025 Q2: 383 adverse event reports received by the FDA (1 death, 347 injury, 35 malfunction and 0 other).","value":383,"unit":"device adverse event reports received","reports":383,"deaths":1,"injuries":347,"malfunctions":35,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OAE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2025 Q2: 381 adverse event reports received by the FDA (10 death, 157 injury, 214 malfunction and 0 other).","value":381,"unit":"device adverse event reports received","reports":381,"deaths":10,"injuries":157,"malfunctions":214,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2025 Q2: 374 adverse event reports received by the FDA (1 death, 132 injury, 241 malfunction and 0 other).","value":374,"unit":"device adverse event reports received","reports":374,"deaths":1,"injuries":132,"malfunctions":241,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OUT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2025 Q2: 367 adverse event reports received by the FDA (14 death, 98 injury, 255 malfunction and 0 other).","value":367,"unit":"device adverse event reports received","reports":367,"deaths":14,"injuries":98,"malfunctions":255,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Instrument, Biopsy (product code KNW), 2025 Q2: 365 adverse event reports received by the FDA (0 death, 85 injury, 280 malfunction and 0 other).","value":365,"unit":"device adverse event reports received","reports":365,"deaths":0,"injuries":85,"malfunctions":280,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KOD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Urological (product code KOD), 2025 Q2: 362 adverse event reports received by the FDA (0 death, 26 injury, 336 malfunction and 0 other).","value":362,"unit":"device adverse event reports received","reports":362,"deaths":0,"injuries":26,"malfunctions":336,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2025 Q2: 358 adverse event reports received by the FDA (1 death, 352 injury, 5 malfunction and 0 other).","value":358,"unit":"device adverse event reports received","reports":358,"deaths":1,"injuries":352,"malfunctions":5,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MFK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2025 Q2: 346 adverse event reports received by the FDA (0 death, 251 injury, 95 malfunction and 0 other).","value":346,"unit":"device adverse event reports received","reports":346,"deaths":0,"injuries":251,"malfunctions":95,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Coude (product code EZC), 2025 Q2: 343 adverse event reports received by the FDA (0 death, 24 injury, 319 malfunction and 0 other).","value":343,"unit":"device adverse event reports received","reports":343,"deaths":0,"injuries":24,"malfunctions":319,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2025 Q2: 335 adverse event reports received by the FDA (0 death, 53 injury, 282 malfunction and 0 other).","value":335,"unit":"device adverse event reports received","reports":335,"deaths":0,"injuries":53,"malfunctions":282,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JXG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2025 Q2: 327 adverse event reports received by the FDA (4 death, 180 injury, 143 malfunction and 0 other).","value":327,"unit":"device adverse event reports received","reports":327,"deaths":4,"injuries":180,"malfunctions":143,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2025 Q2: 327 adverse event reports received by the FDA (1 death, 15 injury, 311 malfunction and 0 other).","value":327,"unit":"device adverse event reports received","reports":327,"deaths":1,"injuries":15,"malfunctions":311,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2025 Q2: 306 adverse event reports received by the FDA (0 death, 1 injury, 305 malfunction and 0 other).","value":306,"unit":"device adverse event reports received","reports":306,"deaths":0,"injuries":1,"malfunctions":305,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KTT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2025 Q2: 304 adverse event reports received by the FDA (0 death, 258 injury, 46 malfunction and 0 other).","value":304,"unit":"device adverse event reports received","reports":304,"deaths":0,"injuries":258,"malfunctions":46,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2025 Q2: 303 adverse event reports received by the FDA (47 death, 38 injury, 218 malfunction and 0 other).","value":303,"unit":"device adverse event reports received","reports":303,"deaths":47,"injuries":38,"malfunctions":218,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GBX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Irrigation (product code GBX), 2025 Q2: 301 adverse event reports received by the FDA (1 death, 32 injury, 268 malfunction and 0 other).","value":301,"unit":"device adverse event reports received","reports":301,"deaths":1,"injuries":32,"malfunctions":268,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2025 Q2: 300 adverse event reports received by the FDA (0 death, 3 injury, 297 malfunction and 0 other).","value":300,"unit":"device adverse event reports received","reports":300,"deaths":0,"injuries":3,"malfunctions":297,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2025 Q2: 299 adverse event reports received by the FDA (2 death, 159 injury, 138 malfunction and 0 other).","value":299,"unit":"device adverse event reports received","reports":299,"deaths":2,"injuries":159,"malfunctions":138,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2025 Q2: 296 adverse event reports received by the FDA (9 death, 24 injury, 263 malfunction and 0 other).","value":296,"unit":"device adverse event reports received","reports":296,"deaths":9,"injuries":24,"malfunctions":263,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2025 Q2: 296 adverse event reports received by the FDA (1 death, 193 injury, 102 malfunction and 0 other).","value":296,"unit":"device adverse event reports received","reports":296,"deaths":1,"injuries":193,"malfunctions":102,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2025 Q2: 289 adverse event reports received by the FDA (12 death, 122 injury, 155 malfunction and 0 other).","value":289,"unit":"device adverse event reports received","reports":289,"deaths":12,"injuries":122,"malfunctions":155,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2025 Q2: 288 adverse event reports received by the FDA (0 death, 284 injury, 4 malfunction and 0 other).","value":288,"unit":"device adverse event reports received","reports":288,"deaths":0,"injuries":284,"malfunctions":4,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2025 Q2: 285 adverse event reports received by the FDA (0 death, 5 injury, 280 malfunction and 0 other).","value":285,"unit":"device adverse event reports received","reports":285,"deaths":0,"injuries":5,"malfunctions":280,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Driver, Prosthesis (product code HWR), 2025 Q2: 283 adverse event reports received by the FDA (0 death, 4 injury, 279 malfunction and 0 other).","value":283,"unit":"device adverse event reports received","reports":283,"deaths":0,"injuries":4,"malfunctions":279,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QCB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2025 Q2: 283 adverse event reports received by the FDA (0 death, 283 injury, 0 malfunction and 0 other).","value":283,"unit":"device adverse event reports received","reports":283,"deaths":0,"injuries":283,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stapler, Surgical (product code GAG), 2025 Q2: 281 adverse event reports received by the FDA (0 death, 40 injury, 241 malfunction and 0 other).","value":281,"unit":"device adverse event reports received","reports":281,"deaths":0,"injuries":40,"malfunctions":241,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LHI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2025 Q2: 281 adverse event reports received by the FDA (0 death, 4 injury, 277 malfunction and 0 other).","value":281,"unit":"device adverse event reports received","reports":281,"deaths":0,"injuries":4,"malfunctions":277,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2025 Q2: 277 adverse event reports received by the FDA (0 death, 7 injury, 270 malfunction and 0 other).","value":277,"unit":"device adverse event reports received","reports":277,"deaths":0,"injuries":7,"malfunctions":270,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MND:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ligator, Esophageal (product code MND), 2025 Q2: 276 adverse event reports received by the FDA (0 death, 17 injury, 259 malfunction and 0 other).","value":276,"unit":"device adverse event reports received","reports":276,"deaths":0,"injuries":17,"malfunctions":259,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNQ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2025 Q2: 276 adverse event reports received by the FDA (0 death, 272 injury, 4 malfunction and 0 other).","value":276,"unit":"device adverse event reports received","reports":276,"deaths":0,"injuries":272,"malfunctions":4,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2025 Q2: 274 adverse event reports received by the FDA (0 death, 262 injury, 12 malfunction and 0 other).","value":274,"unit":"device adverse event reports received","reports":274,"deaths":0,"injuries":262,"malfunctions":12,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JOH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2025 Q2: 270 adverse event reports received by the FDA (1 death, 25 injury, 244 malfunction and 0 other).","value":270,"unit":"device adverse event reports received","reports":270,"deaths":1,"injuries":25,"malfunctions":244,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ODG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2025 Q2: 269 adverse event reports received by the FDA (0 death, 8 injury, 261 malfunction and 0 other).","value":269,"unit":"device adverse event reports received","reports":269,"deaths":0,"injuries":8,"malfunctions":261,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2025 Q2: 267 adverse event reports received by the FDA (0 death, 9 injury, 258 malfunction and 0 other).","value":267,"unit":"device adverse event reports received","reports":267,"deaths":0,"injuries":9,"malfunctions":258,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2025 Q2: 265 adverse event reports received by the FDA (0 death, 1 injury, 264 malfunction and 0 other).","value":265,"unit":"device adverse event reports received","reports":265,"deaths":0,"injuries":1,"malfunctions":264,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stretcher, Wheeled (product code FPO), 2025 Q2: 260 adverse event reports received by the FDA (2 death, 4 injury, 254 malfunction and 0 other).","value":260,"unit":"device adverse event reports received","reports":260,"deaths":2,"injuries":4,"malfunctions":254,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PSV:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2025 Q2: 258 adverse event reports received by the FDA (0 death, 32 injury, 226 malfunction and 0 other).","value":258,"unit":"device adverse event reports received","reports":258,"deaths":0,"injuries":32,"malfunctions":226,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QKP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2025 Q2: 256 adverse event reports received by the FDA (0 death, 0 injury, 255 malfunction and 1 other).","value":256,"unit":"device adverse event reports received","reports":256,"deaths":0,"injuries":0,"malfunctions":255,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PFO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2025 Q2: 253 adverse event reports received by the FDA (0 death, 234 injury, 19 malfunction and 0 other).","value":253,"unit":"device adverse event reports received","reports":253,"deaths":0,"injuries":234,"malfunctions":19,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SBA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2025 Q2: 252 adverse event reports received by the FDA (0 death, 98 injury, 154 malfunction and 0 other).","value":252,"unit":"device adverse event reports received","reports":252,"deaths":0,"injuries":98,"malfunctions":154,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTQ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2025 Q2: 250 adverse event reports received by the FDA (11 death, 7 injury, 232 malfunction and 0 other).","value":250,"unit":"device adverse event reports received","reports":250,"deaths":11,"injuries":7,"malfunctions":232,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2025 Q2: 248 adverse event reports received by the FDA (0 death, 29 injury, 219 malfunction and 0 other).","value":248,"unit":"device adverse event reports received","reports":248,"deaths":0,"injuries":29,"malfunctions":219,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2025 Q2: 240 adverse event reports received by the FDA (6 death, 74 injury, 160 malfunction and 0 other).","value":240,"unit":"device adverse event reports received","reports":240,"deaths":6,"injuries":74,"malfunctions":160,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2025 Q2: 239 adverse event reports received by the FDA (0 death, 233 injury, 6 malfunction and 0 other).","value":239,"unit":"device adverse event reports received","reports":239,"deaths":0,"injuries":233,"malfunctions":6,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2025 Q2: 234 adverse event reports received by the FDA (3 death, 43 injury, 188 malfunction and 0 other).","value":234,"unit":"device adverse event reports received","reports":234,"deaths":3,"injuries":43,"malfunctions":188,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2025 Q2: 231 adverse event reports received by the FDA (3 death, 23 injury, 205 malfunction and 0 other).","value":231,"unit":"device adverse event reports received","reports":231,"deaths":3,"injuries":23,"malfunctions":205,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2025 Q2: 230 adverse event reports received by the FDA (3 death, 154 injury, 73 malfunction and 0 other).","value":230,"unit":"device adverse event reports received","reports":230,"deaths":3,"injuries":154,"malfunctions":73,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MMI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2025 Q2: 225 adverse event reports received by the FDA (0 death, 10 injury, 215 malfunction and 0 other).","value":225,"unit":"device adverse event reports received","reports":225,"deaths":0,"injuries":10,"malfunctions":215,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HHS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2025 Q2: 221 adverse event reports received by the FDA (0 death, 221 injury, 0 malfunction and 0 other).","value":221,"unit":"device adverse event reports received","reports":221,"deaths":0,"injuries":221,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2025 Q2: 220 adverse event reports received by the FDA (0 death, 10 injury, 210 malfunction and 0 other).","value":220,"unit":"device adverse event reports received","reports":220,"deaths":0,"injuries":10,"malfunctions":210,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2025 Q2: 220 adverse event reports received by the FDA (0 death, 9 injury, 211 malfunction and 0 other).","value":220,"unit":"device adverse event reports received","reports":220,"deaths":0,"injuries":9,"malfunctions":211,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2025 Q2: 220 adverse event reports received by the FDA (0 death, 40 injury, 180 malfunction and 0 other).","value":220,"unit":"device adverse event reports received","reports":220,"deaths":0,"injuries":40,"malfunctions":180,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2025 Q2: 218 adverse event reports received by the FDA (20 death, 108 injury, 90 malfunction and 0 other).","value":218,"unit":"device adverse event reports received","reports":218,"deaths":20,"injuries":108,"malfunctions":90,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GIM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2025 Q2: 218 adverse event reports received by the FDA (0 death, 0 injury, 218 malfunction and 0 other).","value":218,"unit":"device adverse event reports received","reports":218,"deaths":0,"injuries":0,"malfunctions":218,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2025 Q2: 214 adverse event reports received by the FDA (0 death, 208 injury, 6 malfunction and 0 other).","value":214,"unit":"device adverse event reports received","reports":214,"deaths":0,"injuries":208,"malfunctions":6,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GWF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2025 Q2: 213 adverse event reports received by the FDA (0 death, 9 injury, 204 malfunction and 0 other).","value":213,"unit":"device adverse event reports received","reports":213,"deaths":0,"injuries":9,"malfunctions":204,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Reamer (product code HTO), 2025 Q2: 212 adverse event reports received by the FDA (0 death, 5 injury, 207 malfunction and 0 other).","value":212,"unit":"device adverse event reports received","reports":212,"deaths":0,"injuries":5,"malfunctions":207,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LNH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2025 Q2: 212 adverse event reports received by the FDA (2 death, 30 injury, 180 malfunction and 0 other).","value":212,"unit":"device adverse event reports received","reports":212,"deaths":2,"injuries":30,"malfunctions":180,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2025 Q2: 209 adverse event reports received by the FDA (0 death, 0 injury, 209 malfunction and 0 other).","value":209,"unit":"device adverse event reports received","reports":209,"deaths":0,"injuries":0,"malfunctions":209,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2025 Q2: 209 adverse event reports received by the FDA (5 death, 22 injury, 182 malfunction and 0 other).","value":209,"unit":"device adverse event reports received","reports":209,"deaths":5,"injuries":22,"malfunctions":182,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2025 Q2: 209 adverse event reports received by the FDA (1 death, 26 injury, 182 malfunction and 0 other).","value":209,"unit":"device adverse event reports received","reports":209,"deaths":1,"injuries":26,"malfunctions":182,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2025 Q2: 209 adverse event reports received by the FDA (4 death, 18 injury, 187 malfunction and 0 other).","value":209,"unit":"device adverse event reports received","reports":209,"deaths":4,"injuries":18,"malfunctions":187,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2025 Q2: 208 adverse event reports received by the FDA (0 death, 5 injury, 203 malfunction and 0 other).","value":208,"unit":"device adverse event reports received","reports":208,"deaths":0,"injuries":5,"malfunctions":203,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2025 Q2: 207 adverse event reports received by the FDA (5 death, 9 injury, 192 malfunction and 1 other).","value":207,"unit":"device adverse event reports received","reports":207,"deaths":5,"injuries":9,"malfunctions":192,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Plate, Bone (product code JEY), 2025 Q2: 206 adverse event reports received by the FDA (0 death, 28 injury, 178 malfunction and 0 other).","value":206,"unit":"device adverse event reports received","reports":206,"deaths":0,"injuries":28,"malfunctions":178,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2025 Q2: 205 adverse event reports received by the FDA (0 death, 34 injury, 171 malfunction and 0 other).","value":205,"unit":"device adverse event reports received","reports":205,"deaths":0,"injuries":34,"malfunctions":171,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2025 Q2: 205 adverse event reports received by the FDA (13 death, 86 injury, 106 malfunction and 0 other).","value":205,"unit":"device adverse event reports received","reports":205,"deaths":13,"injuries":86,"malfunctions":106,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NHA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2025 Q2: 205 adverse event reports received by the FDA (0 death, 67 injury, 138 malfunction and 0 other).","value":205,"unit":"device adverse event reports received","reports":205,"deaths":0,"injuries":67,"malfunctions":138,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ETN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Nerve (product code ETN), 2025 Q2: 199 adverse event reports received by the FDA (0 death, 14 injury, 185 malfunction and 0 other).","value":199,"unit":"device adverse event reports received","reports":199,"deaths":0,"injuries":14,"malfunctions":185,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MLV:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2025 Q2: 199 adverse event reports received by the FDA (3 death, 67 injury, 129 malfunction and 0 other).","value":199,"unit":"device adverse event reports received","reports":199,"deaths":3,"injuries":67,"malfunctions":129,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTZ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2025 Q2: 198 adverse event reports received by the FDA (16 death, 18 injury, 164 malfunction and 0 other).","value":198,"unit":"device adverse event reports received","reports":198,"deaths":16,"injuries":18,"malfunctions":164,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2025 Q2: 198 adverse event reports received by the FDA (0 death, 21 injury, 177 malfunction and 0 other).","value":198,"unit":"device adverse event reports received","reports":198,"deaths":0,"injuries":21,"malfunctions":177,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2025 Q2: 197 adverse event reports received by the FDA (0 death, 2 injury, 195 malfunction and 0 other).","value":197,"unit":"device adverse event reports received","reports":197,"deaths":0,"injuries":2,"malfunctions":195,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Blood Culturing (product code MDB), 2025 Q2: 197 adverse event reports received by the FDA (0 death, 0 injury, 197 malfunction and 0 other).","value":197,"unit":"device adverse event reports received","reports":197,"deaths":0,"injuries":0,"malfunctions":197,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GFD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Dermatome (product code GFD), 2025 Q2: 192 adverse event reports received by the FDA (0 death, 30 injury, 162 malfunction and 0 other).","value":192,"unit":"device adverse event reports received","reports":192,"deaths":0,"injuries":30,"malfunctions":162,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2025 Q2: 188 adverse event reports received by the FDA (0 death, 141 injury, 47 malfunction and 0 other).","value":188,"unit":"device adverse event reports received","reports":188,"deaths":0,"injuries":141,"malfunctions":47,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Programmer, Pacemaker (product code KRG), 2025 Q2: 187 adverse event reports received by the FDA (1 death, 3 injury, 183 malfunction and 0 other).","value":187,"unit":"device adverse event reports received","reports":187,"deaths":1,"injuries":3,"malfunctions":183,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NRY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2025 Q2: 175 adverse event reports received by the FDA (5 death, 52 injury, 118 malfunction and 0 other).","value":175,"unit":"device adverse event reports received","reports":175,"deaths":5,"injuries":52,"malfunctions":118,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2025 Q2: 173 adverse event reports received by the FDA (1 death, 46 injury, 126 malfunction and 0 other).","value":173,"unit":"device adverse event reports received","reports":173,"deaths":1,"injuries":46,"malfunctions":126,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2025 Q2: 170 adverse event reports received by the FDA (0 death, 6 injury, 164 malfunction and 0 other).","value":170,"unit":"device adverse event reports received","reports":170,"deaths":0,"injuries":6,"malfunctions":164,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2025 Q2: 170 adverse event reports received by the FDA (0 death, 170 injury, 0 malfunction and 0 other).","value":170,"unit":"device adverse event reports received","reports":170,"deaths":0,"injuries":170,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2025 Q2: 168 adverse event reports received by the FDA (0 death, 20 injury, 148 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":0,"injuries":20,"malfunctions":148,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Septostomy (product code DXF), 2025 Q2: 166 adverse event reports received by the FDA (6 death, 100 injury, 60 malfunction and 0 other).","value":166,"unit":"device adverse event reports received","reports":166,"deaths":6,"injuries":100,"malfunctions":60,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2025 Q2: 164 adverse event reports received by the FDA (4 death, 6 injury, 154 malfunction and 0 other).","value":164,"unit":"device adverse event reports received","reports":164,"deaths":4,"injuries":6,"malfunctions":154,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:POE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2025 Q2: 164 adverse event reports received by the FDA (0 death, 78 injury, 86 malfunction and 0 other).","value":164,"unit":"device adverse event reports received","reports":164,"deaths":0,"injuries":78,"malfunctions":86,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OBJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2025 Q2: 163 adverse event reports received by the FDA (2 death, 20 injury, 141 malfunction and 0 other).","value":163,"unit":"device adverse event reports received","reports":163,"deaths":2,"injuries":20,"malfunctions":141,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QHJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2025 Q2: 162 adverse event reports received by the FDA (0 death, 82 injury, 80 malfunction and 0 other).","value":162,"unit":"device adverse event reports received","reports":162,"deaths":0,"injuries":82,"malfunctions":80,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2025 Q2: 159 adverse event reports received by the FDA (0 death, 56 injury, 103 malfunction and 0 other).","value":159,"unit":"device adverse event reports received","reports":159,"deaths":0,"injuries":56,"malfunctions":103,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2025 Q2: 155 adverse event reports received by the FDA (0 death, 35 injury, 120 malfunction and 0 other).","value":155,"unit":"device adverse event reports received","reports":155,"deaths":0,"injuries":35,"malfunctions":120,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2025 Q2: 154 adverse event reports received by the FDA (1 death, 6 injury, 147 malfunction and 0 other).","value":154,"unit":"device adverse event reports received","reports":154,"deaths":1,"injuries":6,"malfunctions":147,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stent, Carotid (product code NIM), 2025 Q2: 153 adverse event reports received by the FDA (3 death, 47 injury, 103 malfunction and 0 other).","value":153,"unit":"device adverse event reports received","reports":153,"deaths":3,"injuries":47,"malfunctions":103,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NOU:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2025 Q2: 153 adverse event reports received by the FDA (0 death, 22 injury, 131 malfunction and 0 other).","value":153,"unit":"device adverse event reports received","reports":153,"deaths":0,"injuries":22,"malfunctions":131,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FQH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Lavage, Jet (product code FQH), 2025 Q2: 152 adverse event reports received by the FDA (1 death, 6 injury, 145 malfunction and 0 other).","value":152,"unit":"device adverse event reports received","reports":152,"deaths":1,"injuries":6,"malfunctions":145,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stent, Iliac (product code NIO), 2025 Q2: 152 adverse event reports received by the FDA (0 death, 62 injury, 90 malfunction and 0 other).","value":152,"unit":"device adverse event reports received","reports":152,"deaths":0,"injuries":62,"malfunctions":90,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FCG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Biopsy Needle (product code FCG), 2025 Q2: 150 adverse event reports received by the FDA (0 death, 11 injury, 139 malfunction and 0 other).","value":150,"unit":"device adverse event reports received","reports":150,"deaths":0,"injuries":11,"malfunctions":139,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2025 Q2: 149 adverse event reports received by the FDA (0 death, 48 injury, 101 malfunction and 0 other).","value":149,"unit":"device adverse event reports received","reports":149,"deaths":0,"injuries":48,"malfunctions":101,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2025 Q2: 147 adverse event reports received by the FDA (0 death, 61 injury, 86 malfunction and 0 other).","value":147,"unit":"device adverse event reports received","reports":147,"deaths":0,"injuries":61,"malfunctions":86,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTE:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2025 Q2: 145 adverse event reports received by the FDA (2 death, 10 injury, 133 malfunction and 0 other).","value":145,"unit":"device adverse event reports received","reports":145,"deaths":2,"injuries":10,"malfunctions":133,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAD:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stent, Ureteral (product code FAD), 2025 Q2: 145 adverse event reports received by the FDA (0 death, 15 injury, 130 malfunction and 0 other).","value":145,"unit":"device adverse event reports received","reports":145,"deaths":0,"injuries":15,"malfunctions":130,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2025 Q2: 145 adverse event reports received by the FDA (0 death, 9 injury, 135 malfunction and 1 other).","value":145,"unit":"device adverse event reports received","reports":145,"deaths":0,"injuries":9,"malfunctions":135,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HNN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Knife, Ophthalmic (product code HNN), 2025 Q2: 145 adverse event reports received by the FDA (0 death, 1 injury, 144 malfunction and 0 other).","value":145,"unit":"device adverse event reports received","reports":145,"deaths":0,"injuries":1,"malfunctions":144,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2025 Q2: 144 adverse event reports received by the FDA (0 death, 7 injury, 137 malfunction and 0 other).","value":144,"unit":"device adverse event reports received","reports":144,"deaths":0,"injuries":7,"malfunctions":137,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2025 Q2: 142 adverse event reports received by the FDA (0 death, 8 injury, 134 malfunction and 0 other).","value":142,"unit":"device adverse event reports received","reports":142,"deaths":0,"injuries":8,"malfunctions":134,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GZF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2025 Q2: 141 adverse event reports received by the FDA (1 death, 140 injury, 0 malfunction and 0 other).","value":141,"unit":"device adverse event reports received","reports":141,"deaths":1,"injuries":140,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HCG:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2025 Q2: 139 adverse event reports received by the FDA (0 death, 29 injury, 110 malfunction and 0 other).","value":139,"unit":"device adverse event reports received","reports":139,"deaths":0,"injuries":29,"malfunctions":110,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2025 Q2: 139 adverse event reports received by the FDA (0 death, 18 injury, 121 malfunction and 0 other).","value":139,"unit":"device adverse event reports received","reports":139,"deaths":0,"injuries":18,"malfunctions":121,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEQ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Toothbrush, Powered (product code JEQ), 2025 Q2: 135 adverse event reports received by the FDA (0 death, 4 injury, 131 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":0,"injuries":4,"malfunctions":131,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2025 Q2: 135 adverse event reports received by the FDA (3 death, 32 injury, 100 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":3,"injuries":32,"malfunctions":100,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2025 Q2: 131 adverse event reports received by the FDA (0 death, 10 injury, 121 malfunction and 0 other).","value":131,"unit":"device adverse event reports received","reports":131,"deaths":0,"injuries":10,"malfunctions":121,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Endoscope, Rigid (product code GCM), 2025 Q2: 130 adverse event reports received by the FDA (0 death, 0 injury, 130 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":0,"injuries":0,"malfunctions":130,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FJK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2025 Q2: 127 adverse event reports received by the FDA (0 death, 6 injury, 121 malfunction and 0 other).","value":127,"unit":"device adverse event reports received","reports":127,"deaths":0,"injuries":6,"malfunctions":121,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MTA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2025 Q2: 126 adverse event reports received by the FDA (0 death, 126 injury, 0 malfunction and 0 other).","value":126,"unit":"device adverse event reports received","reports":126,"deaths":0,"injuries":126,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2025 Q2: 126 adverse event reports received by the FDA (0 death, 2 injury, 124 malfunction and 0 other).","value":126,"unit":"device adverse event reports received","reports":126,"deaths":0,"injuries":2,"malfunctions":124,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2025 Q2: 125 adverse event reports received by the FDA (9 death, 53 injury, 63 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":9,"injuries":53,"malfunctions":63,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NQO:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NQO","deviceName":"Prosthesis, Spinous Process Spacer/Plate","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Prosthesis, Spinous Process Spacer/Plate (product code NQO), 2025 Q2: 124 adverse event reports received by the FDA (0 death, 17 injury, 107 malfunction and 0 other).","value":124,"unit":"device adverse event reports received","reports":124,"deaths":0,"injuries":17,"malfunctions":107,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PYX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2025 Q2: 123 adverse event reports received by the FDA (28 death, 53 injury, 42 malfunction and 0 other).","value":123,"unit":"device adverse event reports received","reports":123,"deaths":28,"injuries":53,"malfunctions":42,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Clamp, Vascular (product code DXC), 2025 Q2: 122 adverse event reports received by the FDA (0 death, 20 injury, 101 malfunction and 1 other).","value":122,"unit":"device adverse event reports received","reports":122,"deaths":0,"injuries":20,"malfunctions":101,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Urethroscope (product code FGC), 2025 Q2: 120 adverse event reports received by the FDA (0 death, 0 injury, 120 malfunction and 0 other).","value":120,"unit":"device adverse event reports received","reports":120,"deaths":0,"injuries":0,"malfunctions":120,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HEB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2025 Q2: 119 adverse event reports received by the FDA (0 death, 2 injury, 117 malfunction and 0 other).","value":119,"unit":"device adverse event reports received","reports":119,"deaths":0,"injuries":2,"malfunctions":117,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2025 Q2: 119 adverse event reports received by the FDA (0 death, 1 injury, 118 malfunction and 0 other).","value":119,"unit":"device adverse event reports received","reports":119,"deaths":0,"injuries":1,"malfunctions":118,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2025 Q2: 119 adverse event reports received by the FDA (0 death, 4 injury, 115 malfunction and 0 other).","value":119,"unit":"device adverse event reports received","reports":119,"deaths":0,"injuries":4,"malfunctions":115,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LCJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2025 Q2: 116 adverse event reports received by the FDA (0 death, 103 injury, 13 malfunction and 0 other).","value":116,"unit":"device adverse event reports received","reports":116,"deaths":0,"injuries":103,"malfunctions":13,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2025 Q2: 115 adverse event reports received by the FDA (0 death, 115 injury, 0 malfunction and 0 other).","value":115,"unit":"device adverse event reports received","reports":115,"deaths":0,"injuries":115,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MRM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2025 Q2: 111 adverse event reports received by the FDA (0 death, 20 injury, 91 malfunction and 0 other).","value":111,"unit":"device adverse event reports received","reports":111,"deaths":0,"injuries":20,"malfunctions":91,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONU:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2025 Q2: 109 adverse event reports received by the FDA (4 death, 51 injury, 54 malfunction and 0 other).","value":109,"unit":"device adverse event reports received","reports":109,"deaths":4,"injuries":51,"malfunctions":54,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PRL:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2025 Q2: 109 adverse event reports received by the FDA (1 death, 52 injury, 56 malfunction and 0 other).","value":109,"unit":"device adverse event reports received","reports":109,"deaths":1,"injuries":52,"malfunctions":56,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAB:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2025 Q2: 108 adverse event reports received by the FDA (0 death, 4 injury, 104 malfunction and 0 other).","value":108,"unit":"device adverse event reports received","reports":108,"deaths":0,"injuries":4,"malfunctions":104,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2025 Q2: 106 adverse event reports received by the FDA (0 death, 34 injury, 72 malfunction and 0 other).","value":106,"unit":"device adverse event reports received","reports":106,"deaths":0,"injuries":34,"malfunctions":72,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2025 Q2: 105 adverse event reports received by the FDA (0 death, 37 injury, 68 malfunction and 0 other).","value":105,"unit":"device adverse event reports received","reports":105,"deaths":0,"injuries":37,"malfunctions":68,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Device, Anti-Snoring (product code LRK), 2025 Q2: 104 adverse event reports received by the FDA (0 death, 3 injury, 101 malfunction and 0 other).","value":104,"unit":"device adverse event reports received","reports":104,"deaths":0,"injuries":3,"malfunctions":101,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQK:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2025 Q2: 97 adverse event reports received by the FDA (2 death, 6 injury, 89 malfunction and 0 other).","value":97,"unit":"device adverse event reports received","reports":97,"deaths":2,"injuries":6,"malfunctions":89,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KMY:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2025 Q2: 97 adverse event reports received by the FDA (0 death, 91 injury, 6 malfunction and 0 other).","value":97,"unit":"device adverse event reports received","reports":97,"deaths":0,"injuries":91,"malfunctions":6,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Wheelchair, Powered (product code ITI), 2025 Q2: 96 adverse event reports received by the FDA (2 death, 35 injury, 58 malfunction and 1 other).","value":96,"unit":"device adverse event reports received","reports":96,"deaths":2,"injuries":35,"malfunctions":58,"other":1,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXN:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2025 Q2: 94 adverse event reports received by the FDA (0 death, 17 injury, 77 malfunction and 0 other).","value":94,"unit":"device adverse event reports received","reports":94,"deaths":0,"injuries":17,"malfunctions":77,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Oximeter (product code DQA), 2025 Q2: 90 adverse event reports received by the FDA (4 death, 0 injury, 86 malfunction and 0 other).","value":90,"unit":"device adverse event reports received","reports":90,"deaths":4,"injuries":0,"malfunctions":86,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2025 Q2: 88 adverse event reports received by the FDA (9 death, 76 injury, 3 malfunction and 0 other).","value":88,"unit":"device adverse event reports received","reports":88,"deaths":9,"injuries":76,"malfunctions":3,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FSA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2025 Q2: 86 adverse event reports received by the FDA (7 death, 26 injury, 53 malfunction and 0 other).","value":86,"unit":"device adverse event reports received","reports":86,"deaths":7,"injuries":26,"malfunctions":53,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KGX:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2025 Q2: 83 adverse event reports received by the FDA (0 death, 73 injury, 10 malfunction and 0 other).","value":83,"unit":"device adverse event reports received","reports":83,"deaths":0,"injuries":73,"malfunctions":10,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OCW:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2025 Q2: 81 adverse event reports received by the FDA (0 death, 28 injury, 53 malfunction and 0 other).","value":81,"unit":"device adverse event reports received","reports":81,"deaths":0,"injuries":28,"malfunctions":53,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NSA:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2025 Q2: 80 adverse event reports received by the FDA (2 death, 3 injury, 75 malfunction and 0 other).","value":80,"unit":"device adverse event reports received","reports":80,"deaths":2,"injuries":3,"malfunctions":75,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCT:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2025 Q2: 70 adverse event reports received by the FDA (0 death, 0 injury, 70 malfunction and 0 other).","value":70,"unit":"device adverse event reports received","reports":70,"deaths":0,"injuries":0,"malfunctions":70,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MZF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Test, Hiv Detection (product code MZF), 2025 Q2: 62 adverse event reports received by the FDA (0 death, 2 injury, 60 malfunction and 0 other).","value":62,"unit":"device adverse event reports received","reports":62,"deaths":0,"injuries":2,"malfunctions":60,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LON:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2025 Q2: 57 adverse event reports received by the FDA (0 death, 0 injury, 57 malfunction and 0 other).","value":57,"unit":"device adverse event reports received","reports":57,"deaths":0,"injuries":0,"malfunctions":57,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NZU:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2025 Q2: 45 adverse event reports received by the FDA (0 death, 29 injury, 16 malfunction and 0 other).","value":45,"unit":"device adverse event reports received","reports":45,"deaths":0,"injuries":29,"malfunctions":16,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAF:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2025 Q2: 42 adverse event reports received by the FDA (2 death, 10 injury, 30 malfunction and 0 other).","value":42,"unit":"device adverse event reports received","reports":42,"deaths":2,"injuries":10,"malfunctions":30,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Bariatric Bed (product code OSI), 2025 Q2: 41 adverse event reports received by the FDA (0 death, 2 injury, 39 malfunction and 0 other).","value":41,"unit":"device adverse event reports received","reports":41,"deaths":0,"injuries":2,"malfunctions":39,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDP:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2025 Q2: 40 adverse event reports received by the FDA (0 death, 9 injury, 31 malfunction and 0 other).","value":40,"unit":"device adverse event reports received","reports":40,"deaths":0,"injuries":9,"malfunctions":31,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IOR:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2025 Q2: 38 adverse event reports received by the FDA (0 death, 4 injury, 34 malfunction and 0 other).","value":38,"unit":"device adverse event reports received","reports":38,"deaths":0,"injuries":4,"malfunctions":34,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNM:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2025 Q2: 32 adverse event reports received by the FDA (0 death, 19 injury, 13 malfunction and 0 other).","value":32,"unit":"device adverse event reports received","reports":32,"deaths":0,"injuries":19,"malfunctions":13,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDC:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Calculator, Drug Dose (product code NDC), 2025 Q2: 30 adverse event reports received by the FDA (0 death, 1 injury, 29 malfunction and 0 other).","value":30,"unit":"device adverse event reports received","reports":30,"deaths":0,"injuries":1,"malfunctions":29,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTI:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Compressor, Air, Portable (product code BTI), 2025 Q2: 28 adverse event reports received by the FDA (1 death, 12 injury, 15 malfunction and 0 other).","value":28,"unit":"device adverse event reports received","reports":28,"deaths":1,"injuries":12,"malfunctions":15,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITJ:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Walker, Mechanical (product code ITJ), 2025 Q2: 20 adverse event reports received by the FDA (0 death, 20 injury, 0 malfunction and 0 other).","value":20,"unit":"device adverse event reports received","reports":20,"deaths":0,"injuries":20,"malfunctions":0,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJH:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Orthopedic Tray (product code OJH), 2025 Q2: 12 adverse event reports received by the FDA (0 death, 3 injury, 9 malfunction and 0 other).","value":12,"unit":"device adverse event reports received","reports":12,"deaths":0,"injuries":3,"malfunctions":9,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ILS:2025Q2","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q2","year":2025,"qtr":2,"periodStart":"2025-04-01","periodEnd":"2025-06-30","status":"P","text":"Adaptor, Hygiene (product code ILS), 2025 Q2: 6 adverse event reports received by the FDA (0 death, 4 injury, 2 malfunction and 0 other).","value":6,"unit":"device adverse event reports received","reports":6,"deaths":0,"injuries":4,"malfunctions":2,"other":0,"effectiveFrom":"2025-04-01","effectiveTo":"2025-06-30","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DZE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DZE","deviceName":"Implant, Endosseous, Root-Form","specialty":"Dental","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Implant, Endosseous, Root-Form (product code DZE), 2025 Q1: 181,503 adverse event reports received by the FDA (0 death, 181,190 injury, 312 malfunction and 1 other).","value":181503,"unit":"device adverse event reports received","reports":181503,"deaths":0,"injuries":181190,"malfunctions":312,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QBJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QBJ","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), 2025 Q1: 78,986 adverse event reports received by the FDA (11 death, 2,269 injury, 76,706 malfunction and 0 other).","value":78986,"unit":"device adverse event reports received","reports":78986,"deaths":11,"injuries":2269,"malfunctions":76706,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QFG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QFG","deviceName":"Alternate Controller Enabled Insulin Infusion Pump","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Alternate Controller Enabled Insulin Infusion Pump (product code QFG), 2025 Q1: 71,111 adverse event reports received by the FDA (12 death, 6,829 injury, 64,270 malfunction and 0 other).","value":71111,"unit":"device adverse event reports received","reports":71111,"deaths":12,"injuries":6829,"malfunctions":64270,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BZD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BZD","deviceName":"Ventilator, Non-Continuous (Respirator)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ventilator, Non-Continuous (Respirator) (product code BZD), 2025 Q1: 40,126 adverse event reports received by the FDA (522 death, 4,882 injury, 34,722 malfunction and 0 other).","value":40126,"unit":"device adverse event reports received","reports":40126,"deaths":522,"injuries":4882,"malfunctions":34722,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZP","deviceName":"Automated Insulin Dosing Device System, Single Hormonal Control","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP), 2025 Q1: 30,175 adverse event reports received by the FDA (34 death, 3,236 injury, 26,905 malfunction and 0 other).","value":30175,"unit":"device adverse event reports received","reports":30175,"deaths":34,"injuries":3236,"malfunctions":26905,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FRN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FRN","deviceName":"Pump, Infusion","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pump, Infusion (product code FRN), 2025 Q1: 12,898 adverse event reports received by the FDA (17 death, 185 injury, 12,695 malfunction and 1 other).","value":12898,"unit":"device adverse event reports received","reports":12898,"deaths":17,"injuries":185,"malfunctions":12695,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAY","deviceName":"System, Surgical, Computer Controlled Instrument","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Surgical, Computer Controlled Instrument (product code NAY), 2025 Q1: 12,054 adverse event reports received by the FDA (17 death, 402 injury, 11,633 malfunction and 2 other).","value":12054,"unit":"device adverse event reports received","reports":12054,"deaths":17,"injuries":402,"malfunctions":11633,"other":2,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPA","deviceName":"Set, Administration, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Set, Administration, Intravascular (product code FPA), 2025 Q1: 10,482 adverse event reports received by the FDA (6 death, 1,217 injury, 9,259 malfunction and 0 other).","value":10482,"unit":"device adverse event reports received","reports":10482,"deaths":6,"injuries":1217,"malfunctions":9259,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BRY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BRY","deviceName":"Cabinet, Table And Tray, Anesthesia","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Cabinet, Table And Tray, Anesthesia (product code BRY), 2025 Q1: 10,234 adverse event reports received by the FDA (0 death, 4 injury, 10,230 malfunction and 0 other).","value":10234,"unit":"device adverse event reports received","reports":10234,"deaths":0,"injuries":4,"malfunctions":10230,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LGW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LGW","deviceName":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (product code LGW), 2025 Q1: 7,657 adverse event reports received by the FDA (3 death, 5,961 injury, 1,693 malfunction and 0 other).","value":7657,"unit":"device adverse event reports received","reports":7657,"deaths":3,"injuries":5961,"malfunctions":1693,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PQF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PQF","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive (product code PQF), 2025 Q1: 7,373 adverse event reports received by the FDA (0 death, 26 injury, 7,347 malfunction and 0 other).","value":7373,"unit":"device adverse event reports received","reports":7373,"deaths":0,"injuries":26,"malfunctions":7347,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTR","deviceName":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled (product code FTR), 2025 Q1: 7,339 adverse event reports received by the FDA (0 death, 7,246 injury, 93 malfunction and 0 other).","value":7339,"unit":"device adverse event reports received","reports":7339,"deaths":0,"injuries":7246,"malfunctions":93,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTB","deviceName":"Permanent Pacemaker Electrode","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Permanent Pacemaker Electrode (product code DTB), 2025 Q1: 6,409 adverse event reports received by the FDA (42 death, 2,750 injury, 3,617 malfunction and 0 other).","value":6409,"unit":"device adverse event reports received","reports":6409,"deaths":42,"injuries":2750,"malfunctions":3617,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QLG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QLG","deviceName":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), 2025 Q1: 6,350 adverse event reports received by the FDA (3 death, 1,210 injury, 5,136 malfunction and 1 other).","value":6350,"unit":"device adverse event reports received","reports":6350,"deaths":3,"injuries":1210,"malfunctions":5136,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWS","deviceName":"Implantable Cardioverter Defibrillator (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Implantable Cardioverter Defibrillator (Non-Crt) (product code LWS), 2025 Q1: 5,800 adverse event reports received by the FDA (55 death, 3,306 injury, 2,436 malfunction and 3 other).","value":5800,"unit":"device adverse event reports received","reports":5800,"deaths":55,"injuries":3306,"malfunctions":2436,"other":3,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVN","deviceName":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes (product code NVN), 2025 Q1: 5,796 adverse event reports received by the FDA (77 death, 3,199 injury, 2,515 malfunction and 5 other).","value":5796,"unit":"device adverse event reports received","reports":5796,"deaths":77,"injuries":3199,"malfunctions":2515,"other":5,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CBK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CBK","deviceName":"Ventilator, Continuous, Facility Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ventilator, Continuous, Facility Use (product code CBK), 2025 Q1: 4,209 adverse event reports received by the FDA (33 death, 87 injury, 4,088 malfunction and 1 other).","value":4209,"unit":"device adverse event reports received","reports":4209,"deaths":33,"injuries":87,"malfunctions":4088,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FET:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FET","deviceName":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Endoscopic Video Imaging System/Component, Gastroenterology-Urology (product code FET), 2025 Q1: 3,846 adverse event reports received by the FDA (0 death, 46 injury, 3,800 malfunction and 0 other).","value":3846,"unit":"device adverse event reports received","reports":3846,"deaths":0,"injuries":46,"malfunctions":3800,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MGB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MGB","deviceName":"Device, Hemostasis, Vascular","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Device, Hemostasis, Vascular (product code MGB), 2025 Q1: 3,479 adverse event reports received by the FDA (6 death, 2,724 injury, 749 malfunction and 0 other).","value":3479,"unit":"device adverse event reports received","reports":3479,"deaths":6,"injuries":2724,"malfunctions":749,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MKJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MKJ","deviceName":"Automated External Defibrillators (Non-Wearable)","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Automated External Defibrillators (Non-Wearable) (product code MKJ), 2025 Q1: 3,361 adverse event reports received by the FDA (34 death, 66 injury, 3,260 malfunction and 1 other).","value":3361,"unit":"device adverse event reports received","reports":3361,"deaths":34,"injuries":66,"malfunctions":3260,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZG","deviceName":"Pump, Infusion, Insulin","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pump, Infusion, Insulin (product code LZG), 2025 Q1: 3,321 adverse event reports received by the FDA (4 death, 235 injury, 3,082 malfunction and 0 other).","value":3321,"unit":"device adverse event reports received","reports":3321,"deaths":4,"injuries":235,"malfunctions":3082,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MVK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MVK","deviceName":"Wearable Automated External Defibrillator","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Wearable Automated External Defibrillator (product code MVK), 2025 Q1: 3,224 adverse event reports received by the FDA (94 death, 987 injury, 2,143 malfunction and 0 other).","value":3224,"unit":"device adverse event reports received","reports":3224,"deaths":94,"injuries":987,"malfunctions":2143,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDW","deviceName":"Staple, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Staple, Implantable (product code GDW), 2025 Q1: 3,041 adverse event reports received by the FDA (20 death, 381 injury, 2,640 malfunction and 0 other).","value":3041,"unit":"device adverse event reports received","reports":3041,"deaths":20,"injuries":381,"malfunctions":2640,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPT","deviceName":"Aortic Valve, Prosthesis, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Aortic Valve, Prosthesis, Percutaneously Delivered (product code NPT), 2025 Q1: 3,026 adverse event reports received by the FDA (306 death, 1,924 injury, 796 malfunction and 0 other).","value":3026,"unit":"device adverse event reports received","reports":3026,"deaths":306,"injuries":1924,"malfunctions":796,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKU:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKU","deviceName":"Insulin Pump Secondary Display","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Insulin Pump Secondary Display (product code PKU), 2025 Q1: 2,927 adverse event reports received by the FDA (0 death, 3 injury, 2,924 malfunction and 0 other).","value":2927,"unit":"device adverse event reports received","reports":2927,"deaths":0,"injuries":3,"malfunctions":2924,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OYC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OYC","deviceName":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC), 2025 Q1: 2,886 adverse event reports received by the FDA (1 death, 14 injury, 2,871 malfunction and 0 other).","value":2886,"unit":"device adverse event reports received","reports":2886,"deaths":1,"injuries":14,"malfunctions":2871,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIK","deviceName":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (product code NIK), 2025 Q1: 2,787 adverse event reports received by the FDA (40 death, 1,065 injury, 1,682 malfunction and 0 other).","value":2787,"unit":"device adverse event reports received","reports":2787,"deaths":40,"injuries":1065,"malfunctions":1682,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSQ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSQ","deviceName":"Ventricular (Assist) Bypass","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ventricular (Assist) Bypass (product code DSQ), 2025 Q1: 2,746 adverse event reports received by the FDA (578 death, 1,105 injury, 1,063 malfunction and 0 other).","value":2746,"unit":"device adverse event reports received","reports":2746,"deaths":578,"injuries":1105,"malfunctions":1063,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JWH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JWH","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (product code JWH), 2025 Q1: 2,688 adverse event reports received by the FDA (2 death, 2,463 injury, 223 malfunction and 0 other).","value":2688,"unit":"device adverse event reports received","reports":2688,"deaths":2,"injuries":2463,"malfunctions":223,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NXC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NXC","deviceName":"Aligner, Sequential","specialty":"Dental","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Aligner, Sequential (product code NXC), 2025 Q1: 2,628 adverse event reports received by the FDA (0 death, 2,438 injury, 190 malfunction and 0 other).","value":2628,"unit":"device adverse event reports received","reports":2628,"deaths":0,"injuries":2438,"malfunctions":190,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWP","deviceName":"Implantable Pulse Generator, Pacemaker (Non-Crt)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Implantable Pulse Generator, Pacemaker (Non-Crt) (product code LWP), 2025 Q1: 2,602 adverse event reports received by the FDA (25 death, 1,526 injury, 1,051 malfunction and 0 other).","value":2602,"unit":"device adverse event reports received","reports":2602,"deaths":25,"injuries":1526,"malfunctions":1051,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVY","deviceName":"Permanent Defibrillator Electrodes","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Permanent Defibrillator Electrodes (product code NVY), 2025 Q1: 2,517 adverse event reports received by the FDA (24 death, 1,332 injury, 1,159 malfunction and 2 other).","value":2517,"unit":"device adverse event reports received","reports":2517,"deaths":24,"injuries":1332,"malfunctions":1159,"other":2,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDF","deviceName":"Colonoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Colonoscope And Accessories, Flexible/Rigid (product code FDF), 2025 Q1: 2,510 adverse event reports received by the FDA (0 death, 65 injury, 2,445 malfunction and 0 other).","value":2510,"unit":"device adverse event reports received","reports":2510,"deaths":0,"injuries":65,"malfunctions":2445,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OWB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OWB","deviceName":"Interventional Fluoroscopic X-Ray System","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Interventional Fluoroscopic X-Ray System (product code OWB), 2025 Q1: 2,406 adverse event reports received by the FDA (1 death, 13 injury, 2,392 malfunction and 0 other).","value":2406,"unit":"device adverse event reports received","reports":2406,"deaths":1,"injuries":13,"malfunctions":2392,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FWM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FWM","deviceName":"Prosthesis, Breast, Inflatable, Internal, Saline","specialty":"General, Plastic Surgery","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Breast, Inflatable, Internal, Saline (product code FWM), 2025 Q1: 2,135 adverse event reports received by the FDA (2 death, 2,109 injury, 23 malfunction and 1 other).","value":2135,"unit":"device adverse event reports received","reports":2135,"deaths":2,"injuries":2109,"malfunctions":23,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAM","deviceName":"Suture, Absorbable, Synthetic, Polyglycolic Acid","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), 2025 Q1: 2,089 adverse event reports received by the FDA (2 death, 201 injury, 1,886 malfunction and 0 other).","value":2089,"unit":"device adverse event reports received","reports":2089,"deaths":2,"injuries":201,"malfunctions":1886,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDS","deviceName":"Gastroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Gastroscope And Accessories, Flexible/Rigid (product code FDS), 2025 Q1: 2,015 adverse event reports received by the FDA (0 death, 38 injury, 1,977 malfunction and 0 other).","value":2015,"unit":"device adverse event reports received","reports":2015,"deaths":0,"injuries":38,"malfunctions":1977,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSP","deviceName":"System, Balloon, Intra-Aortic And Control","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Balloon, Intra-Aortic And Control (product code DSP), 2025 Q1: 1,927 adverse event reports received by the FDA (12 death, 27 injury, 1,888 malfunction and 0 other).","value":1927,"unit":"device adverse event reports received","reports":1927,"deaths":12,"injuries":27,"malfunctions":1888,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LXH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LXH","deviceName":"Orthopedic Manual Surgical Instrument","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Orthopedic Manual Surgical Instrument (product code LXH), 2025 Q1: 1,843 adverse event reports received by the FDA (0 death, 51 injury, 1,792 malfunction and 0 other).","value":1843,"unit":"device adverse event reports received","reports":1843,"deaths":0,"injuries":51,"malfunctions":1792,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEI","deviceName":"Electrosurgical, Cutting & Coagulation & Accessories","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Electrosurgical, Cutting & Coagulation & Accessories (product code GEI), 2025 Q1: 1,837 adverse event reports received by the FDA (0 death, 241 injury, 1,595 malfunction and 1 other).","value":1837,"unit":"device adverse event reports received","reports":1837,"deaths":0,"injuries":241,"malfunctions":1595,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZD","deviceName":"Temporary Non-Roller Type Left Heart Support Blood Pump","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Temporary Non-Roller Type Left Heart Support Blood Pump (product code OZD), 2025 Q1: 1,776 adverse event reports received by the FDA (315 death, 727 injury, 734 malfunction and 0 other).","value":1776,"unit":"device adverse event reports received","reports":1776,"deaths":315,"injuries":727,"malfunctions":734,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZW","deviceName":"Stimulator, Electrical, Implantable, For Incontinence","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Electrical, Implantable, For Incontinence (product code EZW), 2025 Q1: 1,548 adverse event reports received by the FDA (0 death, 736 injury, 812 malfunction and 0 other).","value":1548,"unit":"device adverse event reports received","reports":1548,"deaths":0,"injuries":736,"malfunctions":812,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LKK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LKK","deviceName":"Pump, Infusion, Implanted, Programmable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pump, Infusion, Implanted, Programmable (product code LKK), 2025 Q1: 1,462 adverse event reports received by the FDA (1 death, 628 injury, 833 malfunction and 0 other).","value":1462,"unit":"device adverse event reports received","reports":1462,"deaths":1,"injuries":628,"malfunctions":833,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NVZ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NVZ","deviceName":"Pulse Generator, Permanent, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pulse Generator, Permanent, Implantable (product code NVZ), 2025 Q1: 1,435 adverse event reports received by the FDA (31 death, 749 injury, 655 malfunction and 0 other).","value":1435,"unit":"device adverse event reports received","reports":1435,"deaths":31,"injuries":749,"malfunctions":655,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FOZ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FOZ","deviceName":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (product code FOZ), 2025 Q1: 1,395 adverse event reports received by the FDA (0 death, 59 injury, 1,335 malfunction and 1 other).","value":1395,"unit":"device adverse event reports received","reports":1395,"deaths":0,"injuries":59,"malfunctions":1335,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BSZ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BSZ","deviceName":"Gas-Machine, Anesthesia","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Gas-Machine, Anesthesia (product code BSZ), 2025 Q1: 1,394 adverse event reports received by the FDA (1 death, 17 injury, 1,376 malfunction and 0 other).","value":1394,"unit":"device adverse event reports received","reports":1394,"deaths":1,"injuries":17,"malfunctions":1376,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCM","deviceName":"Implant, Cochlear","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Implant, Cochlear (product code MCM), 2025 Q1: 1,362 adverse event reports received by the FDA (1 death, 764 injury, 597 malfunction and 0 other).","value":1362,"unit":"device adverse event reports received","reports":1362,"deaths":1,"injuries":764,"malfunctions":597,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJS","deviceName":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS), 2025 Q1: 1,311 adverse event reports received by the FDA (1 death, 132 injury, 1,178 malfunction and 0 other).","value":1311,"unit":"device adverse event reports received","reports":1311,"deaths":1,"injuries":132,"malfunctions":1178,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JKA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JKA","deviceName":"Tubes, Vials, Systems, Serum Separators, Blood Collection","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), 2025 Q1: 1,305 adverse event reports received by the FDA (0 death, 20 injury, 1,285 malfunction and 0 other).","value":1305,"unit":"device adverse event reports received","reports":1305,"deaths":0,"injuries":20,"malfunctions":1285,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBW","deviceName":"System, Test, Blood Glucose, Over The Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Test, Blood Glucose, Over The Counter (product code NBW), 2025 Q1: 1,293 adverse event reports received by the FDA (0 death, 85 injury, 1,208 malfunction and 0 other).","value":1293,"unit":"device adverse event reports received","reports":1293,"deaths":0,"injuries":85,"malfunctions":1208,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HET:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HET","deviceName":"Laparoscope, Gynecologic (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Laparoscope, Gynecologic (And Accessories) (product code HET), 2025 Q1: 1,292 adverse event reports received by the FDA (0 death, 9 injury, 1,283 malfunction and 0 other).","value":1292,"unit":"device adverse event reports received","reports":1292,"deaths":0,"injuries":9,"malfunctions":1283,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAW","deviceName":"Neurological Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Neurological Stereotaxic Instrument (product code HAW), 2025 Q1: 1,276 adverse event reports received by the FDA (3 death, 29 injury, 1,244 malfunction and 0 other).","value":1276,"unit":"device adverse event reports received","reports":1276,"deaths":3,"injuries":29,"malfunctions":1244,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCJ","deviceName":"Laparoscope, General & Plastic Surgery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Laparoscope, General & Plastic Surgery (product code GCJ), 2025 Q1: 1,266 adverse event reports received by the FDA (1 death, 88 injury, 1,177 malfunction and 0 other).","value":1266,"unit":"device adverse event reports received","reports":1266,"deaths":1,"injuries":88,"malfunctions":1177,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPH","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (product code LPH), 2025 Q1: 1,258 adverse event reports received by the FDA (1 death, 1,135 injury, 122 malfunction and 0 other).","value":1258,"unit":"device adverse event reports received","reports":1258,"deaths":1,"injuries":1135,"malfunctions":122,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQL","deviceName":"Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Intraocular Lens (product code HQL), 2025 Q1: 1,256 adverse event reports received by the FDA (0 death, 197 injury, 1,059 malfunction and 0 other).","value":1256,"unit":"device adverse event reports received","reports":1256,"deaths":0,"injuries":197,"malfunctions":1059,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAD","deviceName":"Vaporizer, Anesthesia, Non-Heated","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Vaporizer, Anesthesia, Non-Heated (product code CAD), 2025 Q1: 1,238 adverse event reports received by the FDA (0 death, 0 injury, 1,238 malfunction and 0 other).","value":1238,"unit":"device adverse event reports received","reports":1238,"deaths":0,"injuries":0,"malfunctions":1238,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OLO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OLO","deviceName":"Orthopedic Stereotaxic Instrument","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Orthopedic Stereotaxic Instrument (product code OLO), 2025 Q1: 1,171 adverse event reports received by the FDA (1 death, 239 injury, 931 malfunction and 0 other).","value":1171,"unit":"device adverse event reports received","reports":1171,"deaths":1,"injuries":239,"malfunctions":931,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OZO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OZO","deviceName":"Automated Insulin Dosing , Threshold Suspend","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Automated Insulin Dosing , Threshold Suspend (product code OZO), 2025 Q1: 1,143 adverse event reports received by the FDA (5 death, 116 injury, 1,022 malfunction and 0 other).","value":1143,"unit":"device adverse event reports received","reports":1143,"deaths":5,"injuries":116,"malfunctions":1022,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JJE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JJE","deviceName":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use","specialty":"Clinical Chemistry","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (product code JJE), 2025 Q1: 1,100 adverse event reports received by the FDA (1 death, 27 injury, 1,072 malfunction and 0 other).","value":1100,"unit":"device adverse event reports received","reports":1100,"deaths":1,"injuries":27,"malfunctions":1072,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOQ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOQ","deviceName":"Bronchoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Bronchoscope (Flexible Or Rigid) (product code EOQ), 2025 Q1: 1,083 adverse event reports received by the FDA (7 death, 119 injury, 957 malfunction and 0 other).","value":1083,"unit":"device adverse event reports received","reports":1083,"deaths":7,"injuries":119,"malfunctions":957,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYB","deviceName":"Introducer, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Introducer, Catheter (product code DYB), 2025 Q1: 992 adverse event reports received by the FDA (45 death, 257 injury, 690 malfunction and 0 other).","value":992,"unit":"device adverse event reports received","reports":992,"deaths":45,"injuries":257,"malfunctions":690,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMF","deviceName":"Syringe, Piston","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Syringe, Piston (product code FMF), 2025 Q1: 986 adverse event reports received by the FDA (1 death, 73 injury, 911 malfunction and 1 other).","value":986,"unit":"device adverse event reports received","reports":986,"deaths":1,"injuries":73,"malfunctions":911,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NAD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NAD","deviceName":"Dressing, Wound, Occlusive","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Dressing, Wound, Occlusive (product code NAD), 2025 Q1: 982 adverse event reports received by the FDA (0 death, 11 injury, 971 malfunction and 0 other).","value":982,"unit":"device adverse event reports received","reports":982,"deaths":0,"injuries":11,"malfunctions":971,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNT","deviceName":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Continuous, Minimal Ventilatory Support, Facility Use Ventilator (product code MNT), 2025 Q1: 968 adverse event reports received by the FDA (2 death, 6 injury, 960 malfunction and 0 other).","value":968,"unit":"device adverse event reports received","reports":968,"deaths":2,"injuries":6,"malfunctions":960,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FTL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FTL","deviceName":"Mesh, Surgical, Polymeric","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Mesh, Surgical, Polymeric (product code FTL), 2025 Q1: 934 adverse event reports received by the FDA (12 death, 881 injury, 41 malfunction and 0 other).","value":934,"unit":"device adverse event reports received","reports":934,"deaths":12,"injuries":881,"malfunctions":41,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEA","deviceName":"Pump, Infusion, Pca","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pump, Infusion, Pca (product code MEA), 2025 Q1: 934 adverse event reports received by the FDA (1 death, 6 injury, 927 malfunction and 0 other).","value":934,"unit":"device adverse event reports received","reports":934,"deaths":1,"injuries":6,"malfunctions":927,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJX","deviceName":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (product code OJX), 2025 Q1: 928 adverse event reports received by the FDA (9 death, 486 injury, 433 malfunction and 0 other).","value":928,"unit":"device adverse event reports received","reports":928,"deaths":9,"injuries":486,"malfunctions":433,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFL","deviceName":"Instrument, Ultrasonic Surgical","specialty":"Unknown","deviceClass":"U","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Instrument, Ultrasonic Surgical (product code LFL), 2025 Q1: 921 adverse event reports received by the FDA (1 death, 28 injury, 892 malfunction and 0 other).","value":921,"unit":"device adverse event reports received","reports":921,"deaths":1,"injuries":28,"malfunctions":892,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRA","deviceName":"Catheter, Steerable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Steerable (product code DRA), 2025 Q1: 897 adverse event reports received by the FDA (12 death, 187 injury, 698 malfunction and 0 other).","value":897,"unit":"device adverse event reports received","reports":897,"deaths":12,"injuries":187,"malfunctions":698,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNJ","deviceName":"Leadless Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Leadless Pacemaker (product code PNJ), 2025 Q1: 884 adverse event reports received by the FDA (49 death, 342 injury, 493 malfunction and 0 other).","value":884,"unit":"device adverse event reports received","reports":884,"deaths":49,"injuries":342,"malfunctions":493,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNS","deviceName":"Ventilator, Continuous, Non-Life-Supporting","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ventilator, Continuous, Non-Life-Supporting (product code MNS), 2025 Q1: 875 adverse event reports received by the FDA (31 death, 18 injury, 826 malfunction and 0 other).","value":875,"unit":"device adverse event reports received","reports":875,"deaths":31,"injuries":18,"malfunctions":826,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DYE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DYE","deviceName":"Replacement Heart-Valve","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Replacement Heart-Valve (product code DYE), 2025 Q1: 869 adverse event reports received by the FDA (3 death, 767 injury, 99 malfunction and 0 other).","value":869,"unit":"device adverse event reports received","reports":869,"deaths":3,"injuries":767,"malfunctions":99,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHY","deviceName":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Electrical, Implanted, For Parkinsonian Tremor (product code MHY), 2025 Q1: 869 adverse event reports received by the FDA (6 death, 412 injury, 451 malfunction and 0 other).","value":869,"unit":"device adverse event reports received","reports":869,"deaths":6,"injuries":412,"malfunctions":451,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MIH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MIH","deviceName":"System, Endovascular Graft, Aortic Aneurysm Treatment","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Endovascular Graft, Aortic Aneurysm Treatment (product code MIH), 2025 Q1: 832 adverse event reports received by the FDA (71 death, 573 injury, 188 malfunction and 0 other).","value":832,"unit":"device adverse event reports received","reports":832,"deaths":71,"injuries":573,"malfunctions":188,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCW","deviceName":"Laryngoscope, Rigid","specialty":"Anesthesiology","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Laryngoscope, Rigid (product code CCW), 2025 Q1: 818 adverse event reports received by the FDA (0 death, 10 injury, 808 malfunction and 0 other).","value":818,"unit":"device adverse event reports received","reports":818,"deaths":0,"injuries":10,"malfunctions":808,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBI","deviceName":"Fastener, Fixation, Nondegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI), 2025 Q1: 816 adverse event reports received by the FDA (0 death, 40 injury, 776 malfunction and 0 other).","value":816,"unit":"device adverse event reports received","reports":816,"deaths":0,"injuries":40,"malfunctions":776,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWB","deviceName":"Endoscope, Accessories, Narrow Band Spectrum","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Endoscope, Accessories, Narrow Band Spectrum (product code NWB), 2025 Q1: 812 adverse event reports received by the FDA (0 death, 7 injury, 805 malfunction and 0 other).","value":812,"unit":"device adverse event reports received","reports":812,"deaths":0,"injuries":7,"malfunctions":805,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRO","deviceName":"General Surgery Tray","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"General Surgery Tray (product code LRO), 2025 Q1: 804 adverse event reports received by the FDA (0 death, 26 injury, 778 malfunction and 0 other).","value":804,"unit":"device adverse event reports received","reports":804,"deaths":0,"injuries":26,"malfunctions":778,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQY","deviceName":"Catheter, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Percutaneous (product code DQY), 2025 Q1: 798 adverse event reports received by the FDA (27 death, 198 injury, 573 malfunction and 0 other).","value":798,"unit":"device adverse event reports received","reports":798,"deaths":27,"injuries":198,"malfunctions":573,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMI","deviceName":"Needle, Hypodermic, Single Lumen","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Needle, Hypodermic, Single Lumen (product code FMI), 2025 Q1: 793 adverse event reports received by the FDA (1 death, 51 injury, 741 malfunction and 0 other).","value":793,"unit":"device adverse event reports received","reports":793,"deaths":1,"injuries":51,"malfunctions":741,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QZI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QZI","deviceName":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (product code QZI), 2025 Q1: 781 adverse event reports received by the FDA (13 death, 292 injury, 475 malfunction and 1 other).","value":781,"unit":"device adverse event reports received","reports":781,"deaths":13,"injuries":292,"malfunctions":475,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNL","deviceName":"Bed, Ac-Powered Adjustable Hospital","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Bed, Ac-Powered Adjustable Hospital (product code FNL), 2025 Q1: 772 adverse event reports received by the FDA (4 death, 43 injury, 725 malfunction and 0 other).","value":772,"unit":"device adverse event reports received","reports":772,"deaths":4,"injuries":43,"malfunctions":725,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBE","deviceName":"Drills, Burrs, Trephines & Accessories (Simple, Powered)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Drills, Burrs, Trephines & Accessories (Simple, Powered) (product code HBE), 2025 Q1: 765 adverse event reports received by the FDA (0 death, 5 injury, 760 malfunction and 0 other).","value":765,"unit":"device adverse event reports received","reports":765,"deaths":0,"injuries":5,"malfunctions":760,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MHX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MHX","deviceName":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX), 2025 Q1: 748 adverse event reports received by the FDA (24 death, 162 injury, 562 malfunction and 0 other).","value":748,"unit":"device adverse event reports received","reports":748,"deaths":24,"injuries":162,"malfunctions":562,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LNH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LNH","deviceName":"System, Nuclear Magnetic Resonance Imaging","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Nuclear Magnetic Resonance Imaging (product code LNH), 2025 Q1: 746 adverse event reports received by the FDA (0 death, 28 injury, 718 malfunction and 0 other).","value":746,"unit":"device adverse event reports received","reports":746,"deaths":0,"injuries":28,"malfunctions":718,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FKX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FKX","deviceName":"System, Peritoneal, Automatic Delivery","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Peritoneal, Automatic Delivery (product code FKX), 2025 Q1: 745 adverse event reports received by the FDA (19 death, 223 injury, 503 malfunction and 0 other).","value":745,"unit":"device adverse event reports received","reports":745,"deaths":19,"injuries":223,"malfunctions":503,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWE","deviceName":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (product code HWE), 2025 Q1: 738 adverse event reports received by the FDA (0 death, 8 injury, 730 malfunction and 0 other).","value":738,"unit":"device adverse event reports received","reports":738,"deaths":0,"injuries":8,"malfunctions":730,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDJ","deviceName":"Set, Administration, For Peritoneal Dialysis, Disposable","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), 2025 Q1: 732 adverse event reports received by the FDA (6 death, 251 injury, 475 malfunction and 0 other).","value":732,"unit":"device adverse event reports received","reports":732,"deaths":6,"injuries":251,"malfunctions":475,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXD","deviceName":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD), 2025 Q1: 727 adverse event reports received by the FDA (1 death, 84 injury, 642 malfunction and 0 other).","value":727,"unit":"device adverse event reports received","reports":727,"deaths":1,"injuries":84,"malfunctions":642,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KDI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KDI","deviceName":"Dialyzer, High Permeability With Or Without Sealed Dialysate System","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), 2025 Q1: 722 adverse event reports received by the FDA (13 death, 75 injury, 633 malfunction and 1 other).","value":722,"unit":"device adverse event reports received","reports":722,"deaths":13,"injuries":75,"malfunctions":633,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LJT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LJT","deviceName":"Port & Catheter, Implanted, Subcutaneous, Intravascular","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), 2025 Q1: 714 adverse event reports received by the FDA (12 death, 435 injury, 267 malfunction and 0 other).","value":714,"unit":"device adverse event reports received","reports":714,"deaths":12,"injuries":435,"malfunctions":267,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWJ","deviceName":"System, Thermal Regulating","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Thermal Regulating (product code DWJ), 2025 Q1: 707 adverse event reports received by the FDA (2 death, 21 injury, 684 malfunction and 0 other).","value":707,"unit":"device adverse event reports received","reports":707,"deaths":2,"injuries":21,"malfunctions":684,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NGV:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NGV","deviceName":"System, Appendage Closure, Left Atrial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Appendage Closure, Left Atrial (product code NGV), 2025 Q1: 703 adverse event reports received by the FDA (95 death, 564 injury, 44 malfunction and 0 other).","value":703,"unit":"device adverse event reports received","reports":703,"deaths":95,"injuries":564,"malfunctions":44,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSB","deviceName":"Rod, Fixation, Intramedullary And Accessories","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Rod, Fixation, Intramedullary And Accessories (product code HSB), 2025 Q1: 702 adverse event reports received by the FDA (1 death, 467 injury, 234 malfunction and 0 other).","value":702,"unit":"device adverse event reports received","reports":702,"deaths":1,"injuries":467,"malfunctions":234,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HXX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HXX","deviceName":"Screwdriver","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Screwdriver (product code HXX), 2025 Q1: 702 adverse event reports received by the FDA (0 death, 5 injury, 697 malfunction and 0 other).","value":702,"unit":"device adverse event reports received","reports":702,"deaths":0,"injuries":5,"malfunctions":697,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWC","deviceName":"Screw, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Screw, Fixation, Bone (product code HWC), 2025 Q1: 684 adverse event reports received by the FDA (0 death, 361 injury, 323 malfunction and 0 other).","value":684,"unit":"device adverse event reports received","reports":684,"deaths":0,"injuries":361,"malfunctions":323,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJC","deviceName":"Catheter, Urological (Antimicrobial) And Accessories","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Urological (Antimicrobial) And Accessories (product code MJC), 2025 Q1: 665 adverse event reports received by the FDA (0 death, 8 injury, 657 malfunction and 0 other).","value":665,"unit":"device adverse event reports received","reports":665,"deaths":0,"injuries":8,"malfunctions":657,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKM","deviceName":"Mitral Valve Repair Devices","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Mitral Valve Repair Devices (product code NKM), 2025 Q1: 664 adverse event reports received by the FDA (41 death, 391 injury, 232 malfunction and 0 other).","value":664,"unit":"device adverse event reports received","reports":664,"deaths":41,"injuries":391,"malfunctions":232,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAT","deviceName":"Suture, Nonabsorbable, Synthetic, Polyethylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), 2025 Q1: 660 adverse event reports received by the FDA (0 death, 37 injury, 623 malfunction and 0 other).","value":660,"unit":"device adverse event reports received","reports":660,"deaths":0,"injuries":37,"malfunctions":623,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LZO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LZO","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO), 2025 Q1: 654 adverse event reports received by the FDA (0 death, 546 injury, 108 malfunction and 0 other).","value":654,"unit":"device adverse event reports received","reports":654,"deaths":0,"injuries":546,"malfunctions":108,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FHW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FHW","deviceName":"Device, Impotence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Device, Impotence, Mechanical/Hydraulic (product code FHW), 2025 Q1: 650 adverse event reports received by the FDA (0 death, 598 injury, 52 malfunction and 0 other).","value":650,"unit":"device adverse event reports received","reports":650,"deaths":0,"injuries":598,"malfunctions":52,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIQ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIQ","deviceName":"Coronary Drug-Eluting Stent","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Coronary Drug-Eluting Stent (product code NIQ), 2025 Q1: 649 adverse event reports received by the FDA (43 death, 308 injury, 296 malfunction and 2 other).","value":649,"unit":"device adverse event reports received","reports":649,"deaths":43,"injuries":308,"malfunctions":296,"other":2,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEX","deviceName":"Powered Laser Surgical Instrument","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Powered Laser Surgical Instrument (product code GEX), 2025 Q1: 638 adverse event reports received by the FDA (2 death, 110 injury, 526 malfunction and 0 other).","value":638,"unit":"device adverse event reports received","reports":638,"deaths":2,"injuries":110,"malfunctions":526,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWS","deviceName":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (product code KWS), 2025 Q1: 605 adverse event reports received by the FDA (0 death, 524 injury, 81 malfunction and 0 other).","value":605,"unit":"device adverse event reports received","reports":605,"deaths":0,"injuries":524,"malfunctions":81,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZE","deviceName":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated (product code PZE), 2025 Q1: 591 adverse event reports received by the FDA (0 death, 141 injury, 450 malfunction and 0 other).","value":591,"unit":"device adverse event reports received","reports":591,"deaths":0,"injuries":141,"malfunctions":450,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAW","deviceName":"Suture, Nonabsorbable, Synthetic, Polypropylene","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), 2025 Q1: 581 adverse event reports received by the FDA (1 death, 117 injury, 463 malfunction and 0 other).","value":581,"unit":"device adverse event reports received","reports":581,"deaths":1,"injuries":117,"malfunctions":463,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRX","deviceName":"Arthroscope","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Arthroscope (product code HRX), 2025 Q1: 565 adverse event reports received by the FDA (0 death, 15 injury, 550 malfunction and 0 other).","value":565,"unit":"device adverse event reports received","reports":565,"deaths":0,"injuries":15,"malfunctions":550,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MOM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MOM","deviceName":"System, Hemodynamic, Implantable","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Hemodynamic, Implantable (product code MOM), 2025 Q1: 562 adverse event reports received by the FDA (0 death, 150 injury, 412 malfunction and 0 other).","value":562,"unit":"device adverse event reports received","reports":562,"deaths":0,"injuries":150,"malfunctions":412,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PMP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PMP","deviceName":"Dorsal Root Ganglion Stimulator For Pain Relief","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Dorsal Root Ganglion Stimulator For Pain Relief (product code PMP), 2025 Q1: 548 adverse event reports received by the FDA (0 death, 540 injury, 8 malfunction and 0 other).","value":548,"unit":"device adverse event reports received","reports":548,"deaths":0,"injuries":540,"malfunctions":8,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HRS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HRS","deviceName":"Plate, Fixation, Bone","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Plate, Fixation, Bone (product code HRS), 2025 Q1: 542 adverse event reports received by the FDA (1 death, 429 injury, 112 malfunction and 0 other).","value":542,"unit":"device adverse event reports received","reports":542,"deaths":1,"injuries":429,"malfunctions":112,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PHX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PHX","deviceName":"Shoulder Prosthesis, Reverse Configuration","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Shoulder Prosthesis, Reverse Configuration (product code PHX), 2025 Q1: 535 adverse event reports received by the FDA (0 death, 446 injury, 89 malfunction and 0 other).","value":535,"unit":"device adverse event reports received","reports":535,"deaths":0,"injuries":446,"malfunctions":89,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NEW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NEW","deviceName":"Suture, Surgical, Absorbable, Polydioxanone","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Suture, Surgical, Absorbable, Polydioxanone (product code NEW), 2025 Q1: 516 adverse event reports received by the FDA (0 death, 100 injury, 416 malfunction and 0 other).","value":516,"unit":"device adverse event reports received","reports":516,"deaths":0,"injuries":100,"malfunctions":416,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTC","deviceName":"Analyzer, Pacemaker Generator Function","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Analyzer, Pacemaker Generator Function (product code DTC), 2025 Q1: 513 adverse event reports received by the FDA (1 death, 3 injury, 509 malfunction and 0 other).","value":513,"unit":"device adverse event reports received","reports":513,"deaths":1,"injuries":3,"malfunctions":509,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KOD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KOD","deviceName":"Catheter, Urological","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Urological (product code KOD), 2025 Q1: 512 adverse event reports received by the FDA (0 death, 31 injury, 481 malfunction and 0 other).","value":512,"unit":"device adverse event reports received","reports":512,"deaths":0,"injuries":31,"malfunctions":481,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZY","deviceName":"Device, Incontinence, Mechanical/Hydraulic","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Device, Incontinence, Mechanical/Hydraulic (product code EZY), 2025 Q1: 508 adverse event reports received by the FDA (0 death, 502 injury, 6 malfunction and 0 other).","value":508,"unit":"device adverse event reports received","reports":508,"deaths":0,"injuries":502,"malfunctions":6,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LOX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LOX","deviceName":"Catheters, Transluminal Coronary Angioplasty, Percutaneous","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), 2025 Q1: 506 adverse event reports received by the FDA (41 death, 157 injury, 308 malfunction and 0 other).","value":506,"unit":"device adverse event reports received","reports":506,"deaths":41,"injuries":157,"malfunctions":308,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQX","deviceName":"Wire, Guide, Catheter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Wire, Guide, Catheter (product code DQX), 2025 Q1: 502 adverse event reports received by the FDA (7 death, 214 injury, 281 malfunction and 0 other).","value":502,"unit":"device adverse event reports received","reports":502,"deaths":7,"injuries":214,"malfunctions":281,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OUT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OUT","deviceName":"Intracranial Aneurysm Flow Diverter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Intracranial Aneurysm Flow Diverter (product code OUT), 2025 Q1: 491 adverse event reports received by the FDA (20 death, 114 injury, 357 malfunction and 0 other).","value":491,"unit":"device adverse event reports received","reports":491,"deaths":20,"injuries":114,"malfunctions":357,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JDI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JDI","deviceName":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (product code JDI), 2025 Q1: 472 adverse event reports received by the FDA (7 death, 423 injury, 42 malfunction and 0 other).","value":472,"unit":"device adverse event reports received","reports":472,"deaths":7,"injuries":423,"malfunctions":42,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGE","deviceName":"Stents, Drains And Dilators For The Biliary Ducts","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stents, Drains And Dilators For The Biliary Ducts (product code FGE), 2025 Q1: 464 adverse event reports received by the FDA (2 death, 68 injury, 394 malfunction and 0 other).","value":464,"unit":"device adverse event reports received","reports":464,"deaths":2,"injuries":68,"malfunctions":394,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FDT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FDT","deviceName":"Duodenoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Duodenoscope And Accessories, Flexible/Rigid (product code FDT), 2025 Q1: 463 adverse event reports received by the FDA (3 death, 80 injury, 380 malfunction and 0 other).","value":463,"unit":"device adverse event reports received","reports":463,"deaths":3,"injuries":80,"malfunctions":380,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LWR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LWR","deviceName":"Heart-Valve, Non-Allograft Tissue","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Heart-Valve, Non-Allograft Tissue (product code LWR), 2025 Q1: 462 adverse event reports received by the FDA (15 death, 400 injury, 47 malfunction and 0 other).","value":462,"unit":"device adverse event reports received","reports":462,"deaths":15,"injuries":400,"malfunctions":47,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LIT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LIT","deviceName":"Catheter, Angioplasty, Peripheral, Transluminal","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), 2025 Q1: 460 adverse event reports received by the FDA (0 death, 51 injury, 409 malfunction and 0 other).","value":460,"unit":"device adverse event reports received","reports":460,"deaths":0,"injuries":51,"malfunctions":409,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAI","deviceName":"Fastener, Fixation, Biodegradable, Soft Tissue","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), 2025 Q1: 454 adverse event reports received by the FDA (0 death, 19 injury, 435 malfunction and 0 other).","value":454,"unit":"device adverse event reports received","reports":454,"deaths":0,"injuries":19,"malfunctions":435,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HBB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HBB","deviceName":"Motor, Drill, Pneumatic","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Motor, Drill, Pneumatic (product code HBB), 2025 Q1: 451 adverse event reports received by the FDA (0 death, 2 injury, 449 malfunction and 0 other).","value":451,"unit":"device adverse event reports received","reports":451,"deaths":0,"injuries":2,"malfunctions":449,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWT","deviceName":"Template","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Template (product code HWT), 2025 Q1: 441 adverse event reports received by the FDA (0 death, 9 injury, 432 malfunction and 0 other).","value":441,"unit":"device adverse event reports received","reports":441,"deaths":0,"injuries":9,"malfunctions":432,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDS","deviceName":"Sensor, Glucose, Invasive","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Sensor, Glucose, Invasive (product code MDS), 2025 Q1: 439 adverse event reports received by the FDA (0 death, 13 injury, 424 malfunction and 2 other).","value":439,"unit":"device adverse event reports received","reports":439,"deaths":0,"injuries":13,"malfunctions":424,"other":2,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKE","deviceName":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) (product code NKE), 2025 Q1: 427 adverse event reports received by the FDA (5 death, 257 injury, 165 malfunction and 0 other).","value":427,"unit":"device adverse event reports received","reports":427,"deaths":5,"injuries":257,"malfunctions":165,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ERL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ERL","deviceName":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (product code ERL), 2025 Q1: 420 adverse event reports received by the FDA (0 death, 4 injury, 416 malfunction and 0 other).","value":420,"unit":"device adverse event reports received","reports":420,"deaths":0,"injuries":4,"malfunctions":416,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTR","deviceName":"Tube, Tracheal (W/Wo Connector)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tube, Tracheal (W/Wo Connector) (product code BTR), 2025 Q1: 416 adverse event reports received by the FDA (5 death, 33 injury, 378 malfunction and 0 other).","value":416,"unit":"device adverse event reports received","reports":416,"deaths":5,"injuries":33,"malfunctions":378,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JCW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JCW","deviceName":"Prosthesis, Penis, Inflatable","specialty":"Gastroenterology, Urology","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Penis, Inflatable (product code JCW), 2025 Q1: 412 adverse event reports received by the FDA (1 death, 384 injury, 27 malfunction and 0 other).","value":412,"unit":"device adverse event reports received","reports":412,"deaths":1,"injuries":384,"malfunctions":27,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZP","deviceName":"Clip, Implantable","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Clip, Implantable (product code FZP), 2025 Q1: 411 adverse event reports received by the FDA (0 death, 10 injury, 401 malfunction and 0 other).","value":411,"unit":"device adverse event reports received","reports":411,"deaths":0,"injuries":10,"malfunctions":401,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SAF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SAF","deviceName":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter (product code SAF), 2025 Q1: 411 adverse event reports received by the FDA (0 death, 34 injury, 377 malfunction and 0 other).","value":411,"unit":"device adverse event reports received","reports":411,"deaths":0,"injuries":34,"malfunctions":377,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ETN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ETN","deviceName":"Stimulator, Nerve","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Nerve (product code ETN), 2025 Q1: 397 adverse event reports received by the FDA (0 death, 11 injury, 386 malfunction and 0 other).","value":397,"unit":"device adverse event reports received","reports":397,"deaths":0,"injuries":11,"malfunctions":386,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRD","deviceName":"Device, Vascular, For Promoting Embolization","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Device, Vascular, For Promoting Embolization (product code KRD), 2025 Q1: 397 adverse event reports received by the FDA (3 death, 71 injury, 323 malfunction and 0 other).","value":397,"unit":"device adverse event reports received","reports":397,"deaths":3,"injuries":71,"malfunctions":323,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIH","deviceName":"Hysteroscope (And Accessories)","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Hysteroscope (And Accessories) (product code HIH), 2025 Q1: 395 adverse event reports received by the FDA (1 death, 59 injury, 335 malfunction and 0 other).","value":395,"unit":"device adverse event reports received","reports":395,"deaths":1,"injuries":59,"malfunctions":335,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWA","deviceName":"Impactor","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Impactor (product code HWA), 2025 Q1: 395 adverse event reports received by the FDA (0 death, 2 injury, 393 malfunction and 0 other).","value":395,"unit":"device adverse event reports received","reports":395,"deaths":0,"injuries":2,"malfunctions":393,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HQC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HQC","deviceName":"Unit, Phacofragmentation","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Unit, Phacofragmentation (product code HQC), 2025 Q1: 392 adverse event reports received by the FDA (0 death, 84 injury, 308 malfunction and 0 other).","value":392,"unit":"device adverse event reports received","reports":392,"deaths":0,"injuries":84,"malfunctions":308,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OAE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OAE","deviceName":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE), 2025 Q1: 385 adverse event reports received by the FDA (11 death, 164 injury, 210 malfunction and 0 other).","value":385,"unit":"device adverse event reports received","reports":385,"deaths":11,"injuries":164,"malfunctions":210,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MEB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MEB","deviceName":"Pump, Infusion, Elastomeric","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pump, Infusion, Elastomeric (product code MEB), 2025 Q1: 376 adverse event reports received by the FDA (0 death, 2 injury, 373 malfunction and 1 other).","value":376,"unit":"device adverse event reports received","reports":376,"deaths":0,"injuries":2,"malfunctions":373,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LMH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LMH","deviceName":"Implant, Dermal, For Aesthetic Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Implant, Dermal, For Aesthetic Use (product code LMH), 2025 Q1: 375 adverse event reports received by the FDA (0 death, 375 injury, 0 malfunction and 0 other).","value":375,"unit":"device adverse event reports received","reports":375,"deaths":0,"injuries":375,"malfunctions":0,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTW","deviceName":"Bit, Drill","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Bit, Drill (product code HTW), 2025 Q1: 362 adverse event reports received by the FDA (0 death, 19 injury, 343 malfunction and 0 other).","value":362,"unit":"device adverse event reports received","reports":362,"deaths":0,"injuries":19,"malfunctions":343,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRA","deviceName":"Catheter, Continuous Flush","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Continuous Flush (product code KRA), 2025 Q1: 354 adverse event reports received by the FDA (11 death, 44 injury, 299 malfunction and 0 other).","value":354,"unit":"device adverse event reports received","reports":354,"deaths":11,"injuries":44,"malfunctions":299,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LYJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LYJ","deviceName":"Stimulator, Autonomic Nerve, Implanted For Epilepsy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Autonomic Nerve, Implanted For Epilepsy (product code LYJ), 2025 Q1: 352 adverse event reports received by the FDA (17 death, 143 injury, 192 malfunction and 0 other).","value":352,"unit":"device adverse event reports received","reports":352,"deaths":17,"injuries":143,"malfunctions":192,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LPB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LPB","deviceName":"Cardiac Ablation Percutaneous Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Cardiac Ablation Percutaneous Catheter (product code LPB), 2025 Q1: 348 adverse event reports received by the FDA (14 death, 128 injury, 206 malfunction and 0 other).","value":348,"unit":"device adverse event reports received","reports":348,"deaths":14,"injuries":128,"malfunctions":206,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IZI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IZI","deviceName":"System, X-Ray, Angiographic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, X-Ray, Angiographic (product code IZI), 2025 Q1: 347 adverse event reports received by the FDA (0 death, 0 injury, 345 malfunction and 2 other).","value":347,"unit":"device adverse event reports received","reports":347,"deaths":0,"injuries":0,"malfunctions":345,"other":2,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNT","deviceName":"Tubes, Gastrointestinal (And Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tubes, Gastrointestinal (And Accessories) (product code KNT), 2025 Q1: 347 adverse event reports received by the FDA (4 death, 198 injury, 145 malfunction and 0 other).","value":347,"unit":"device adverse event reports received","reports":347,"deaths":4,"injuries":198,"malfunctions":145,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MJP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MJP","deviceName":"Lens, Intraocular, Toric Optics","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Lens, Intraocular, Toric Optics (product code MJP), 2025 Q1: 341 adverse event reports received by the FDA (0 death, 140 injury, 201 malfunction and 0 other).","value":341,"unit":"device adverse event reports received","reports":341,"deaths":0,"injuries":140,"malfunctions":201,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNW","deviceName":"Instrument, Biopsy","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Instrument, Biopsy (product code KNW), 2025 Q1: 340 adverse event reports received by the FDA (0 death, 46 injury, 294 malfunction and 0 other).","value":340,"unit":"device adverse event reports received","reports":340,"deaths":0,"injuries":46,"malfunctions":294,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JOH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JOH","deviceName":"Tube Tracheostomy And Tube Cuff","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tube Tracheostomy And Tube Cuff (product code JOH), 2025 Q1: 337 adverse event reports received by the FDA (0 death, 28 injury, 309 malfunction and 0 other).","value":337,"unit":"device adverse event reports received","reports":337,"deaths":0,"injuries":28,"malfunctions":309,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWF","deviceName":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), 2025 Q1: 329 adverse event reports received by the FDA (13 death, 17 injury, 299 malfunction and 0 other).","value":329,"unit":"device adverse event reports received","reports":329,"deaths":13,"injuries":17,"malfunctions":299,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PKL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PKL","deviceName":"Hemostatic Metal Clip For The Gi Tract","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Hemostatic Metal Clip For The Gi Tract (product code PKL), 2025 Q1: 329 adverse event reports received by the FDA (0 death, 31 injury, 298 malfunction and 0 other).","value":329,"unit":"device adverse event reports received","reports":329,"deaths":0,"injuries":31,"malfunctions":298,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSD","deviceName":"Catheter, Hemodialysis, Implanted","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Hemodialysis, Implanted (product code MSD), 2025 Q1: 325 adverse event reports received by the FDA (4 death, 51 injury, 270 malfunction and 0 other).","value":325,"unit":"device adverse event reports received","reports":325,"deaths":4,"injuries":51,"malfunctions":270,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZL","deviceName":"Catheter, Retention Type, Balloon","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Retention Type, Balloon (product code EZL), 2025 Q1: 324 adverse event reports received by the FDA (2 death, 55 injury, 267 malfunction and 0 other).","value":324,"unit":"device adverse event reports received","reports":324,"deaths":2,"injuries":55,"malfunctions":267,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NKB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NKB","deviceName":"Thoracolumbosacral Pedicle Screw System","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Thoracolumbosacral Pedicle Screw System (product code NKB), 2025 Q1: 324 adverse event reports received by the FDA (0 death, 139 injury, 185 malfunction and 0 other).","value":324,"unit":"device adverse event reports received","reports":324,"deaths":0,"injuries":139,"malfunctions":185,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GWF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GWF","deviceName":"Stimulator, Electrical, Evoked Response","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Electrical, Evoked Response (product code GWF), 2025 Q1: 315 adverse event reports received by the FDA (0 death, 6 injury, 306 malfunction and 3 other).","value":315,"unit":"device adverse event reports received","reports":315,"deaths":0,"injuries":6,"malfunctions":306,"other":3,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LHI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LHI","deviceName":"Set, I.V. Fluid Transfer","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Set, I.V. Fluid Transfer (product code LHI), 2025 Q1: 313 adverse event reports received by the FDA (0 death, 5 injury, 308 malfunction and 0 other).","value":313,"unit":"device adverse event reports received","reports":313,"deaths":0,"injuries":5,"malfunctions":308,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSN","deviceName":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN), 2025 Q1: 305 adverse event reports received by the FDA (0 death, 299 injury, 6 malfunction and 0 other).","value":305,"unit":"device adverse event reports received","reports":305,"deaths":0,"injuries":299,"malfunctions":6,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HIF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HIF","deviceName":"Insufflator, Laparoscopic","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Insufflator, Laparoscopic (product code HIF), 2025 Q1: 303 adverse event reports received by the FDA (1 death, 33 injury, 269 malfunction and 0 other).","value":303,"unit":"device adverse event reports received","reports":303,"deaths":1,"injuries":33,"malfunctions":269,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MBH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MBH","deviceName":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer (product code MBH), 2025 Q1: 297 adverse event reports received by the FDA (0 death, 218 injury, 79 malfunction and 0 other).","value":297,"unit":"device adverse event reports received","reports":297,"deaths":0,"injuries":218,"malfunctions":79,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWA","deviceName":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)","specialty":"Orthopedic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (product code KWA), 2025 Q1: 296 adverse event reports received by the FDA (1 death, 180 injury, 115 malfunction and 0 other).","value":296,"unit":"device adverse event reports received","reports":296,"deaths":1,"injuries":180,"malfunctions":115,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MFK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MFK","deviceName":"Lens, Multifocal Intraocular","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Lens, Multifocal Intraocular (product code MFK), 2025 Q1: 294 adverse event reports received by the FDA (0 death, 186 injury, 108 malfunction and 0 other).","value":294,"unit":"device adverse event reports received","reports":294,"deaths":0,"injuries":186,"malfunctions":108,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EOB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EOB","deviceName":"Nasopharyngoscope (Flexible Or Rigid)","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Nasopharyngoscope (Flexible Or Rigid) (product code EOB), 2025 Q1: 284 adverse event reports received by the FDA (0 death, 2 injury, 282 malfunction and 0 other).","value":284,"unit":"device adverse event reports received","reports":284,"deaths":0,"injuries":2,"malfunctions":282,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DSI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DSI","deviceName":"Detector And Alarm, Arrhythmia","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Detector And Alarm, Arrhythmia (product code DSI), 2025 Q1: 283 adverse event reports received by the FDA (6 death, 17 injury, 260 malfunction and 0 other).","value":283,"unit":"device adverse event reports received","reports":283,"deaths":6,"injuries":17,"malfunctions":260,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HTO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HTO","deviceName":"Reamer","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Reamer (product code HTO), 2025 Q1: 278 adverse event reports received by the FDA (0 death, 5 injury, 273 malfunction and 0 other).","value":278,"unit":"device adverse event reports received","reports":278,"deaths":0,"injuries":5,"malfunctions":273,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QCB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QCB","deviceName":"Phakic Toric Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Phakic Toric Intraocular Lens (product code QCB), 2025 Q1: 278 adverse event reports received by the FDA (0 death, 277 injury, 1 malfunction and 0 other).","value":278,"unit":"device adverse event reports received","reports":278,"deaths":0,"injuries":277,"malfunctions":1,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HWR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HWR","deviceName":"Driver, Prosthesis","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Driver, Prosthesis (product code HWR), 2025 Q1: 271 adverse event reports received by the FDA (0 death, 1 injury, 270 malfunction and 0 other).","value":271,"unit":"device adverse event reports received","reports":271,"deaths":0,"injuries":1,"malfunctions":270,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:EZC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"EZC","deviceName":"Catheter, Coude","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Coude (product code EZC), 2025 Q1: 268 adverse event reports received by the FDA (0 death, 23 injury, 245 malfunction and 0 other).","value":268,"unit":"device adverse event reports received","reports":268,"deaths":0,"injuries":23,"malfunctions":245,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JXG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JXG","deviceName":"Shunt, Central Nervous System And Components","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Shunt, Central Nervous System And Components (product code JXG), 2025 Q1: 263 adverse event reports received by the FDA (0 death, 183 injury, 80 malfunction and 0 other).","value":263,"unit":"device adverse event reports received","reports":263,"deaths":0,"injuries":183,"malfunctions":80,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CCK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CCK","deviceName":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK), 2025 Q1: 262 adverse event reports received by the FDA (2 death, 0 injury, 260 malfunction and 0 other).","value":262,"unit":"device adverse event reports received","reports":262,"deaths":2,"injuries":0,"malfunctions":260,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GBX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GBX","deviceName":"Catheter, Irrigation","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Irrigation (product code GBX), 2025 Q1: 262 adverse event reports received by the FDA (0 death, 28 injury, 233 malfunction and 1 other).","value":262,"unit":"device adverse event reports received","reports":262,"deaths":0,"injuries":28,"malfunctions":233,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KNS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KNS","deviceName":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories)","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS), 2025 Q1: 261 adverse event reports received by the FDA (2 death, 54 injury, 205 malfunction and 0 other).","value":261,"unit":"device adverse event reports received","reports":261,"deaths":2,"injuries":54,"malfunctions":205,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAX","deviceName":"Intervertebral Fusion Device With Bone Graft, Lumbar","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Intervertebral Fusion Device With Bone Graft, Lumbar (product code MAX), 2025 Q1: 261 adverse event reports received by the FDA (1 death, 49 injury, 211 malfunction and 0 other).","value":261,"unit":"device adverse event reports received","reports":261,"deaths":1,"injuries":49,"malfunctions":211,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NWX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NWX","deviceName":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (product code NWX), 2025 Q1: 261 adverse event reports received by the FDA (11 death, 38 injury, 212 malfunction and 0 other).","value":261,"unit":"device adverse event reports received","reports":261,"deaths":11,"injuries":38,"malfunctions":212,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MXC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MXC","deviceName":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC), 2025 Q1: 259 adverse event reports received by the FDA (0 death, 27 injury, 232 malfunction and 0 other).","value":259,"unit":"device adverse event reports received","reports":259,"deaths":0,"injuries":27,"malfunctions":232,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ODG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ODG","deviceName":"Endoscopic Ultrasound System, Gastroenterology-Urology","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Endoscopic Ultrasound System, Gastroenterology-Urology (product code ODG), 2025 Q1: 257 adverse event reports received by the FDA (2 death, 8 injury, 247 malfunction and 0 other).","value":257,"unit":"device adverse event reports received","reports":257,"deaths":2,"injuries":8,"malfunctions":247,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QKP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QKP","deviceName":"Coronavirus Antigen Detection Test System.","specialty":"Unknown","deviceClass":"N","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Coronavirus Antigen Detection Test System. (product code QKP), 2025 Q1: 257 adverse event reports received by the FDA (0 death, 4 injury, 253 malfunction and 0 other).","value":257,"unit":"device adverse event reports received","reports":257,"deaths":0,"injuries":4,"malfunctions":253,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FPO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FPO","deviceName":"Stretcher, Wheeled","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stretcher, Wheeled (product code FPO), 2025 Q1: 249 adverse event reports received by the FDA (0 death, 4 injury, 245 malfunction and 0 other).","value":249,"unit":"device adverse event reports received","reports":249,"deaths":0,"injuries":4,"malfunctions":245,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FMG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FMG","deviceName":"Stopcock, I.V. Set","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stopcock, I.V. Set (product code FMG), 2025 Q1: 247 adverse event reports received by the FDA (0 death, 5 injury, 242 malfunction and 0 other).","value":247,"unit":"device adverse event reports received","reports":247,"deaths":0,"injuries":5,"malfunctions":242,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAJ","deviceName":"Cystoscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Cystoscope And Accessories, Flexible/Rigid (product code FAJ), 2025 Q1: 246 adverse event reports received by the FDA (0 death, 8 injury, 238 malfunction and 0 other).","value":246,"unit":"device adverse event reports received","reports":246,"deaths":0,"injuries":8,"malfunctions":238,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAG","deviceName":"Stapler, Surgical","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stapler, Surgical (product code GAG), 2025 Q1: 245 adverse event reports received by the FDA (2 death, 49 injury, 194 malfunction and 0 other).","value":245,"unit":"device adverse event reports received","reports":245,"deaths":2,"injuries":49,"malfunctions":194,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJL","deviceName":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing (product code NJL), 2025 Q1: 244 adverse event reports received by the FDA (0 death, 243 injury, 1 malfunction and 0 other).","value":244,"unit":"device adverse event reports received","reports":244,"deaths":0,"injuries":243,"malfunctions":1,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GEY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GEY","deviceName":"Motor, Surgical Instrument, Ac-Powered","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Motor, Surgical Instrument, Ac-Powered (product code GEY), 2025 Q1: 242 adverse event reports received by the FDA (0 death, 2 injury, 240 malfunction and 0 other).","value":242,"unit":"device adverse event reports received","reports":242,"deaths":0,"injuries":2,"malfunctions":240,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HHS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HHS","deviceName":"Transcervical Contraceptive Tubal Occlusion Device","specialty":"Obstetrics/Gynecology","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Transcervical Contraceptive Tubal Occlusion Device (product code HHS), 2025 Q1: 242 adverse event reports received by the FDA (2 death, 240 injury, 0 malfunction and 0 other).","value":242,"unit":"device adverse event reports received","reports":242,"deaths":2,"injuries":240,"malfunctions":0,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIP","deviceName":"Stent, Superficial Femoral Artery","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stent, Superficial Femoral Artery (product code NIP), 2025 Q1: 238 adverse event reports received by the FDA (7 death, 75 injury, 156 malfunction and 0 other).","value":238,"unit":"device adverse event reports received","reports":238,"deaths":7,"injuries":75,"malfunctions":156,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:SBA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"SBA","deviceName":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate (product code SBA), 2025 Q1: 235 adverse event reports received by the FDA (0 death, 74 injury, 161 malfunction and 0 other).","value":235,"unit":"device adverse event reports received","reports":235,"deaths":0,"injuries":74,"malfunctions":161,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PFO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PFO","deviceName":"Active Implantable Bone Conduction Hearing System","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Active Implantable Bone Conduction Hearing System (product code PFO), 2025 Q1: 233 adverse event reports received by the FDA (0 death, 205 injury, 28 malfunction and 0 other).","value":233,"unit":"device adverse event reports received","reports":233,"deaths":0,"injuries":205,"malfunctions":28,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOK","deviceName":"Dermal Cooling Pack/Vacuum/Massager","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Dermal Cooling Pack/Vacuum/Massager (product code OOK), 2025 Q1: 227 adverse event reports received by the FDA (0 death, 216 injury, 11 malfunction and 0 other).","value":227,"unit":"device adverse event reports received","reports":227,"deaths":0,"injuries":216,"malfunctions":11,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MND:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MND","deviceName":"Ligator, Esophageal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ligator, Esophageal (product code MND), 2025 Q1: 226 adverse event reports received by the FDA (0 death, 8 injury, 218 malfunction and 0 other).","value":226,"unit":"device adverse event reports received","reports":226,"deaths":0,"injuries":8,"malfunctions":218,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LFR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LFR","deviceName":"Glucose Dehydrogenase, Glucose","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Glucose Dehydrogenase, Glucose (product code LFR), 2025 Q1: 224 adverse event reports received by the FDA (0 death, 11 injury, 213 malfunction and 0 other).","value":224,"unit":"device adverse event reports received","reports":224,"deaths":0,"injuries":11,"malfunctions":213,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PSV:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PSV","deviceName":"Ultrasound Bronchoscope","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ultrasound Bronchoscope (product code PSV), 2025 Q1: 209 adverse event reports received by the FDA (0 death, 7 injury, 202 malfunction and 0 other).","value":209,"unit":"device adverse event reports received","reports":209,"deaths":0,"injuries":7,"malfunctions":202,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTQ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTQ","deviceName":"Console, Heart-Lung Machine, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Console, Heart-Lung Machine, Cardiopulmonary Bypass (product code DTQ), 2025 Q1: 207 adverse event reports received by the FDA (2 death, 3 injury, 202 malfunction and 0 other).","value":207,"unit":"device adverse event reports received","reports":207,"deaths":2,"injuries":3,"malfunctions":202,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGC","deviceName":"Urethroscope","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Urethroscope (product code FGC), 2025 Q1: 198 adverse event reports received by the FDA (0 death, 0 injury, 198 malfunction and 0 other).","value":198,"unit":"device adverse event reports received","reports":198,"deaths":0,"injuries":0,"malfunctions":198,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MNQ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MNQ","deviceName":"Stimulator, Hypoglossal Nerve, Implanted, Apnea","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Hypoglossal Nerve, Implanted, Apnea (product code MNQ), 2025 Q1: 196 adverse event reports received by the FDA (1 death, 189 injury, 6 malfunction and 0 other).","value":196,"unit":"device adverse event reports received","reports":196,"deaths":1,"injuries":189,"malfunctions":6,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NOU:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NOU","deviceName":"Continuous, Ventilator, Home Use","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Continuous, Ventilator, Home Use (product code NOU), 2025 Q1: 195 adverse event reports received by the FDA (0 death, 5 injury, 190 malfunction and 0 other).","value":195,"unit":"device adverse event reports received","reports":195,"deaths":0,"injuries":5,"malfunctions":190,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPS","deviceName":"Tricuspid Valve Repair Device, Percutaneously Delivered","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tricuspid Valve Repair Device, Percutaneously Delivered (product code NPS), 2025 Q1: 195 adverse event reports received by the FDA (11 death, 132 injury, 52 malfunction and 0 other).","value":195,"unit":"device adverse event reports received","reports":195,"deaths":11,"injuries":132,"malfunctions":52,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HNN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HNN","deviceName":"Knife, Ophthalmic","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Knife, Ophthalmic (product code HNN), 2025 Q1: 193 adverse event reports received by the FDA (0 death, 24 injury, 169 malfunction and 0 other).","value":193,"unit":"device adverse event reports received","reports":193,"deaths":0,"injuries":24,"malfunctions":169,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXY","deviceName":"Implantable Pacemaker Pulse-Generator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Implantable Pacemaker Pulse-Generator (product code DXY), 2025 Q1: 192 adverse event reports received by the FDA (6 death, 96 injury, 90 malfunction and 0 other).","value":192,"unit":"device adverse event reports received","reports":192,"deaths":6,"injuries":96,"malfunctions":90,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWT","deviceName":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (product code KWT), 2025 Q1: 190 adverse event reports received by the FDA (0 death, 179 injury, 11 malfunction and 0 other).","value":190,"unit":"device adverse event reports received","reports":190,"deaths":0,"injuries":179,"malfunctions":11,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAR","deviceName":"Suture, Nonabsorbable, Synthetic, Polyamide","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), 2025 Q1: 185 adverse event reports received by the FDA (0 death, 9 injury, 176 malfunction and 0 other).","value":185,"unit":"device adverse event reports received","reports":185,"deaths":0,"injuries":9,"malfunctions":176,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FZX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FZX","deviceName":"Guide, Surgical, Instrument","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Guide, Surgical, Instrument (product code FZX), 2025 Q1: 184 adverse event reports received by the FDA (0 death, 67 injury, 117 malfunction and 0 other).","value":184,"unit":"device adverse event reports received","reports":184,"deaths":0,"injuries":67,"malfunctions":117,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GFD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GFD","deviceName":"Dermatome","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Dermatome (product code GFD), 2025 Q1: 182 adverse event reports received by the FDA (0 death, 7 injury, 175 malfunction and 0 other).","value":182,"unit":"device adverse event reports received","reports":182,"deaths":0,"injuries":7,"malfunctions":175,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTZ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTZ","deviceName":"Oxygenator, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Oxygenator, Cardiopulmonary Bypass (product code DTZ), 2025 Q1: 178 adverse event reports received by the FDA (10 death, 17 injury, 151 malfunction and 0 other).","value":178,"unit":"device adverse event reports received","reports":178,"deaths":10,"injuries":17,"malfunctions":151,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MTA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MTA","deviceName":"Lens, Intraocular, Phakic","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Lens, Intraocular, Phakic (product code MTA), 2025 Q1: 176 adverse event reports received by the FDA (0 death, 176 injury, 0 malfunction and 0 other).","value":176,"unit":"device adverse event reports received","reports":176,"deaths":0,"injuries":176,"malfunctions":0,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KWP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KWP","deviceName":"Appliance, Fixation, Spinal Interlaminal","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Appliance, Fixation, Spinal Interlaminal (product code KWP), 2025 Q1: 174 adverse event reports received by the FDA (0 death, 44 injury, 130 malfunction and 0 other).","value":174,"unit":"device adverse event reports received","reports":174,"deaths":0,"injuries":44,"malfunctions":130,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NHA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NHA","deviceName":"Abutment, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Abutment, Implant, Dental, Endosseous (product code NHA), 2025 Q1: 172 adverse event reports received by the FDA (1 death, 82 injury, 89 malfunction and 0 other).","value":172,"unit":"device adverse event reports received","reports":172,"deaths":1,"injuries":82,"malfunctions":89,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GZF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GZF","deviceName":"Stimulator, Peripheral Nerve, Implanted (Pain Relief)","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stimulator, Peripheral Nerve, Implanted (Pain Relief) (product code GZF), 2025 Q1: 169 adverse event reports received by the FDA (0 death, 166 injury, 3 malfunction and 0 other).","value":169,"unit":"device adverse event reports received","reports":169,"deaths":0,"injuries":166,"malfunctions":3,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCM","deviceName":"Endoscope, Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Endoscope, Rigid (product code GCM), 2025 Q1: 168 adverse event reports received by the FDA (0 death, 0 injury, 168 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":0,"injuries":0,"malfunctions":168,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OBJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OBJ","deviceName":"Catheter, Ultrasound, Intravascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Ultrasound, Intravascular (product code OBJ), 2025 Q1: 168 adverse event reports received by the FDA (3 death, 24 injury, 141 malfunction and 0 other).","value":168,"unit":"device adverse event reports received","reports":168,"deaths":3,"injuries":24,"malfunctions":141,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FCG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FCG","deviceName":"Biopsy Needle","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Biopsy Needle (product code FCG), 2025 Q1: 167 adverse event reports received by the FDA (1 death, 33 injury, 133 malfunction and 0 other).","value":167,"unit":"device adverse event reports received","reports":167,"deaths":1,"injuries":33,"malfunctions":133,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HSD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HSD","deviceName":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), 2025 Q1: 166 adverse event reports received by the FDA (0 death, 145 injury, 21 malfunction and 0 other).","value":166,"unit":"device adverse event reports received","reports":166,"deaths":0,"injuries":145,"malfunctions":21,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIO","deviceName":"Stent, Iliac","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stent, Iliac (product code NIO), 2025 Q1: 165 adverse event reports received by the FDA (16 death, 58 injury, 91 malfunction and 0 other).","value":165,"unit":"device adverse event reports received","reports":165,"deaths":16,"injuries":58,"malfunctions":91,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYO","deviceName":"System, Imaging, Pulsed Echo, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), 2025 Q1: 163 adverse event reports received by the FDA (0 death, 0 injury, 163 malfunction and 0 other).","value":163,"unit":"device adverse event reports received","reports":163,"deaths":0,"injuries":0,"malfunctions":163,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MLV:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MLV","deviceName":"Transcatheter Septal Occluder","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Transcatheter Septal Occluder (product code MLV), 2025 Q1: 163 adverse event reports received by the FDA (1 death, 47 injury, 115 malfunction and 0 other).","value":163,"unit":"device adverse event reports received","reports":163,"deaths":1,"injuries":47,"malfunctions":115,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITX","deviceName":"Transducer, Ultrasonic, Diagnostic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Transducer, Ultrasonic, Diagnostic (product code ITX), 2025 Q1: 161 adverse event reports received by the FDA (1 death, 4 injury, 156 malfunction and 0 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":1,"injuries":4,"malfunctions":156,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MMI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MMI","deviceName":"Immunoassay Method, Troponin Subunit","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Immunoassay Method, Troponin Subunit (product code MMI), 2025 Q1: 161 adverse event reports received by the FDA (0 death, 4 injury, 157 malfunction and 0 other).","value":161,"unit":"device adverse event reports received","reports":161,"deaths":0,"injuries":4,"malfunctions":157,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCX","deviceName":"Catheter, Coronary, Atherectomy","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Coronary, Atherectomy (product code MCX), 2025 Q1: 158 adverse event reports received by the FDA (15 death, 51 injury, 92 malfunction and 0 other).","value":158,"unit":"device adverse event reports received","reports":158,"deaths":15,"injuries":51,"malfunctions":92,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTT","deviceName":"Humidifier, Respiratory Gas, (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Humidifier, Respiratory Gas, (Direct Patient Interface) (product code BTT), 2025 Q1: 157 adverse event reports received by the FDA (1 death, 5 injury, 151 malfunction and 0 other).","value":157,"unit":"device adverse event reports received","reports":157,"deaths":1,"injuries":5,"malfunctions":151,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONB","deviceName":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (product code ONB), 2025 Q1: 157 adverse event reports received by the FDA (0 death, 2 injury, 151 malfunction and 4 other).","value":157,"unit":"device adverse event reports received","reports":157,"deaths":0,"injuries":2,"malfunctions":151,"other":4,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRM","deviceName":"Compressor, Cardiac, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Compressor, Cardiac, External (product code DRM), 2025 Q1: 156 adverse event reports received by the FDA (0 death, 3 injury, 153 malfunction and 0 other).","value":156,"unit":"device adverse event reports received","reports":156,"deaths":0,"injuries":3,"malfunctions":153,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRG","deviceName":"Programmer, Pacemaker","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Programmer, Pacemaker (product code KRG), 2025 Q1: 156 adverse event reports received by the FDA (0 death, 3 injury, 153 malfunction and 0 other).","value":156,"unit":"device adverse event reports received","reports":156,"deaths":0,"injuries":3,"malfunctions":153,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NRY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NRY","deviceName":"Catheter, Thrombus Retriever","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Thrombus Retriever (product code NRY), 2025 Q1: 156 adverse event reports received by the FDA (12 death, 35 injury, 109 malfunction and 0 other).","value":156,"unit":"device adverse event reports received","reports":156,"deaths":12,"injuries":35,"malfunctions":109,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NBH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NBH","deviceName":"Accessories, Arthroscopic","specialty":"Orthopedic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Accessories, Arthroscopic (product code NBH), 2025 Q1: 154 adverse event reports received by the FDA (0 death, 11 injury, 143 malfunction and 0 other).","value":154,"unit":"device adverse event reports received","reports":154,"deaths":0,"injuries":11,"malfunctions":143,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FGB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FGB","deviceName":"Ureteroscope And Accessories, Flexible/Rigid","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ureteroscope And Accessories, Flexible/Rigid (product code FGB), 2025 Q1: 148 adverse event reports received by the FDA (0 death, 11 injury, 137 malfunction and 0 other).","value":148,"unit":"device adverse event reports received","reports":148,"deaths":0,"injuries":11,"malfunctions":137,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQK","deviceName":"Computer, Diagnostic, Programmable","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Computer, Diagnostic, Programmable (product code DQK), 2025 Q1: 146 adverse event reports received by the FDA (0 death, 3 injury, 143 malfunction and 0 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":3,"malfunctions":143,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MCW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MCW","deviceName":"Catheter, Peripheral, Atherectomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Peripheral, Atherectomy (product code MCW), 2025 Q1: 146 adverse event reports received by the FDA (0 death, 35 injury, 111 malfunction and 0 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":35,"malfunctions":111,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MSS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MSS","deviceName":"Folders And Injectors, Intraocular Lens (Iol)","specialty":"Ophthalmic","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Folders And Injectors, Intraocular Lens (Iol) (product code MSS), 2025 Q1: 146 adverse event reports received by the FDA (0 death, 14 injury, 132 malfunction and 0 other).","value":146,"unit":"device adverse event reports received","reports":146,"deaths":0,"injuries":14,"malfunctions":132,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MAH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MAH","deviceName":"Hearing Aid, Bone Conduction, Implanted","specialty":"Ear, Nose, Throat","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Hearing Aid, Bone Conduction, Implanted (product code MAH), 2025 Q1: 144 adverse event reports received by the FDA (0 death, 144 injury, 0 malfunction and 0 other).","value":144,"unit":"device adverse event reports received","reports":144,"deaths":0,"injuries":144,"malfunctions":0,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DTE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DTE","deviceName":"Pulse-Generator, Pacemaker, External","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pulse-Generator, Pacemaker, External (product code DTE), 2025 Q1: 143 adverse event reports received by the FDA (1 death, 11 injury, 131 malfunction and 0 other).","value":143,"unit":"device adverse event reports received","reports":143,"deaths":1,"injuries":11,"malfunctions":131,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAW","deviceName":"Generator, Oxygen, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Generator, Oxygen, Portable (product code CAW), 2025 Q1: 141 adverse event reports received by the FDA (12 death, 21 injury, 108 malfunction and 0 other).","value":141,"unit":"device adverse event reports received","reports":141,"deaths":12,"injuries":21,"malfunctions":108,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FSA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FSA","deviceName":"Lift, Patient, Non-Ac-Powered","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Lift, Patient, Non-Ac-Powered (product code FSA), 2025 Q1: 140 adverse event reports received by the FDA (8 death, 33 injury, 99 malfunction and 0 other).","value":140,"unit":"device adverse event reports received","reports":140,"deaths":8,"injuries":33,"malfunctions":99,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FQH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FQH","deviceName":"Lavage, Jet","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Lavage, Jet (product code FQH), 2025 Q1: 138 adverse event reports received by the FDA (0 death, 4 injury, 134 malfunction and 0 other).","value":138,"unit":"device adverse event reports received","reports":138,"deaths":0,"injuries":4,"malfunctions":134,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KMY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KMY","deviceName":"Positioner, Tooth, Preformed","specialty":"Dental","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Positioner, Tooth, Preformed (product code KMY), 2025 Q1: 138 adverse event reports received by the FDA (0 death, 129 injury, 9 malfunction and 0 other).","value":138,"unit":"device adverse event reports received","reports":138,"deaths":0,"injuries":129,"malfunctions":9,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QHJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QHJ","deviceName":"Sensor, Glucose, Implanted, Non-Adjunctive Use","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Sensor, Glucose, Implanted, Non-Adjunctive Use (product code QHJ), 2025 Q1: 137 adverse event reports received by the FDA (0 death, 64 injury, 73 malfunction and 0 other).","value":137,"unit":"device adverse event reports received","reports":137,"deaths":0,"injuries":64,"malfunctions":73,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQO","deviceName":"Catheter, Intravascular, Diagnostic","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Intravascular, Diagnostic (product code DQO), 2025 Q1: 135 adverse event reports received by the FDA (2 death, 31 injury, 102 malfunction and 0 other).","value":135,"unit":"device adverse event reports received","reports":135,"deaths":2,"injuries":31,"malfunctions":102,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DWC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DWC","deviceName":"Controller, Temperature, Cardiopulmonary Bypass","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Controller, Temperature, Cardiopulmonary Bypass (product code DWC), 2025 Q1: 134 adverse event reports received by the FDA (1 death, 0 injury, 133 malfunction and 0 other).","value":134,"unit":"device adverse event reports received","reports":134,"deaths":1,"injuries":0,"malfunctions":133,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEY:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEY","deviceName":"Plate, Bone","specialty":"Dental","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Plate, Bone (product code JEY), 2025 Q1: 134 adverse event reports received by the FDA (0 death, 22 injury, 112 malfunction and 0 other).","value":134,"unit":"device adverse event reports received","reports":134,"deaths":0,"injuries":22,"malfunctions":112,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FAD:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FAD","deviceName":"Stent, Ureteral","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stent, Ureteral (product code FAD), 2025 Q1: 133 adverse event reports received by the FDA (0 death, 19 injury, 113 malfunction and 1 other).","value":133,"unit":"device adverse event reports received","reports":133,"deaths":0,"injuries":19,"malfunctions":113,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITI","deviceName":"Wheelchair, Powered","specialty":"Physical Medicine","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Wheelchair, Powered (product code ITI), 2025 Q1: 133 adverse event reports received by the FDA (0 death, 25 injury, 108 malfunction and 0 other).","value":133,"unit":"device adverse event reports received","reports":133,"deaths":0,"injuries":25,"malfunctions":108,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXF","deviceName":"Catheter, Septostomy","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Septostomy (product code DXF), 2025 Q1: 131 adverse event reports received by the FDA (7 death, 74 injury, 50 malfunction and 0 other).","value":131,"unit":"device adverse event reports received","reports":131,"deaths":7,"injuries":74,"malfunctions":50,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PRL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PRL","deviceName":"Iliac Covered Stent, Arterial","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Iliac Covered Stent, Arterial (product code PRL), 2025 Q1: 130 adverse event reports received by the FDA (9 death, 52 injury, 69 malfunction and 0 other).","value":130,"unit":"device adverse event reports received","reports":130,"deaths":9,"injuries":52,"malfunctions":69,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NJE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NJE","deviceName":"Intracranial Neurovascular Stent","specialty":"Unknown","deviceClass":"f","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Intracranial Neurovascular Stent (product code NJE), 2025 Q1: 129 adverse event reports received by the FDA (1 death, 5 injury, 123 malfunction and 0 other).","value":129,"unit":"device adverse event reports received","reports":129,"deaths":1,"injuries":5,"malfunctions":123,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GIM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GIM","deviceName":"Tubes, Vacuum Sample, With Anticoagulant","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tubes, Vacuum Sample, With Anticoagulant (product code GIM), 2025 Q1: 128 adverse event reports received by the FDA (0 death, 0 injury, 128 malfunction and 0 other).","value":128,"unit":"device adverse event reports received","reports":128,"deaths":0,"injuries":0,"malfunctions":128,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KTT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KTT","deviceName":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT), 2025 Q1: 125 adverse event reports received by the FDA (0 death, 90 injury, 35 malfunction and 0 other).","value":125,"unit":"device adverse event reports received","reports":125,"deaths":0,"injuries":90,"malfunctions":35,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFT","deviceName":"Electrode, Ph, Stomach","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Electrode, Ph, Stomach (product code FFT), 2025 Q1: 123 adverse event reports received by the FDA (0 death, 36 injury, 87 malfunction and 0 other).","value":123,"unit":"device adverse event reports received","reports":123,"deaths":0,"injuries":36,"malfunctions":87,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IYN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IYN","deviceName":"System, Imaging, Pulsed Doppler, Ultrasonic","specialty":"Radiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Imaging, Pulsed Doppler, Ultrasonic (product code IYN), 2025 Q1: 122 adverse event reports received by the FDA (1 death, 11 injury, 110 malfunction and 0 other).","value":122,"unit":"device adverse event reports received","reports":122,"deaths":1,"injuries":11,"malfunctions":110,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:POE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"POE","deviceName":"Extended Depth Of Focus Intraocular Lens","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Extended Depth Of Focus Intraocular Lens (product code POE), 2025 Q1: 122 adverse event reports received by the FDA (0 death, 65 injury, 57 malfunction and 0 other).","value":122,"unit":"device adverse event reports received","reports":122,"deaths":0,"injuries":65,"malfunctions":57,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HAB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HAB","deviceName":"Saw, Powered, And Accessories","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Saw, Powered, And Accessories (product code HAB), 2025 Q1: 121 adverse event reports received by the FDA (0 death, 2 injury, 119 malfunction and 0 other).","value":121,"unit":"device adverse event reports received","reports":121,"deaths":0,"injuries":2,"malfunctions":119,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PNO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PNO","deviceName":"Catheter, Percutaneous, Cutting/Scoring","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Percutaneous, Cutting/Scoring (product code PNO), 2025 Q1: 121 adverse event reports received by the FDA (0 death, 4 injury, 117 malfunction and 0 other).","value":121,"unit":"device adverse event reports received","reports":121,"deaths":0,"injuries":4,"malfunctions":117,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KRO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KRO","deviceName":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer (product code KRO), 2025 Q1: 119 adverse event reports received by the FDA (0 death, 117 injury, 2 malfunction and 0 other).","value":119,"unit":"device adverse event reports received","reports":119,"deaths":0,"injuries":117,"malfunctions":2,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HCG:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HCG","deviceName":"Device, Neurovascular Embolization","specialty":"Neurology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Device, Neurovascular Embolization (product code HCG), 2025 Q1: 118 adverse event reports received by the FDA (2 death, 22 injury, 94 malfunction and 0 other).","value":118,"unit":"device adverse event reports received","reports":118,"deaths":2,"injuries":22,"malfunctions":94,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDN","deviceName":"Cement, Bone, Vertebroplasty","specialty":"Orthopedic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Cement, Bone, Vertebroplasty (product code NDN), 2025 Q1: 118 adverse event reports received by the FDA (0 death, 7 injury, 111 malfunction and 0 other).","value":118,"unit":"device adverse event reports received","reports":118,"deaths":0,"injuries":7,"malfunctions":111,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DRF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DRF","deviceName":"Catheter, Electrode Recording, Or Probe, Electrode Recording","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), 2025 Q1: 116 adverse event reports received by the FDA (2 death, 50 injury, 64 malfunction and 0 other).","value":116,"unit":"device adverse event reports received","reports":116,"deaths":2,"injuries":50,"malfunctions":64,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LON:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LON","deviceName":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), 2025 Q1: 116 adverse event reports received by the FDA (0 death, 0 injury, 116 malfunction and 0 other).","value":116,"unit":"device adverse event reports received","reports":116,"deaths":0,"injuries":0,"malfunctions":116,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOI","deviceName":"Real Time Nucleic Acid Amplification System","specialty":"Clinical Chemistry","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Real Time Nucleic Acid Amplification System (product code OOI), 2025 Q1: 116 adverse event reports received by the FDA (0 death, 2 injury, 114 malfunction and 0 other).","value":116,"unit":"device adverse event reports received","reports":116,"deaths":0,"injuries":2,"malfunctions":114,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LCJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LCJ","deviceName":"Tissue Expander And Accessories","specialty":"Unknown","deviceClass":"U","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tissue Expander And Accessories (product code LCJ), 2025 Q1: 112 adverse event reports received by the FDA (0 death, 95 injury, 17 malfunction and 0 other).","value":112,"unit":"device adverse event reports received","reports":112,"deaths":0,"injuries":95,"malfunctions":17,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MRM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MRM","deviceName":"Defibrillator, Implantable, Dual-Chamber","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Defibrillator, Implantable, Dual-Chamber (product code MRM), 2025 Q1: 110 adverse event reports received by the FDA (0 death, 18 injury, 92 malfunction and 0 other).","value":110,"unit":"device adverse event reports received","reports":110,"deaths":0,"injuries":18,"malfunctions":92,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GDO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GDO","deviceName":"Applier, Surgical, Clip","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Applier, Surgical, Clip (product code GDO), 2025 Q1: 108 adverse event reports received by the FDA (0 death, 4 injury, 104 malfunction and 0 other).","value":108,"unit":"device adverse event reports received","reports":108,"deaths":0,"injuries":4,"malfunctions":104,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FJK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FJK","deviceName":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (product code FJK), 2025 Q1: 107 adverse event reports received by the FDA (3 death, 2 injury, 102 malfunction and 0 other).","value":107,"unit":"device adverse event reports received","reports":107,"deaths":3,"injuries":2,"malfunctions":102,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GCT:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GCT","deviceName":"Light Source, Endoscope, Xenon Arc","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Light Source, Endoscope, Xenon Arc (product code GCT), 2025 Q1: 104 adverse event reports received by the FDA (0 death, 0 injury, 104 malfunction and 0 other).","value":104,"unit":"device adverse event reports received","reports":104,"deaths":0,"injuries":0,"malfunctions":104,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:HEB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"HEB","deviceName":"Tampon, Menstrual, Unscented","specialty":"Obstetrics/Gynecology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tampon, Menstrual, Unscented (product code HEB), 2025 Q1: 103 adverse event reports received by the FDA (0 death, 3 injury, 100 malfunction and 0 other).","value":103,"unit":"device adverse event reports received","reports":103,"deaths":0,"injuries":3,"malfunctions":100,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ONU:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ONU","deviceName":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU), 2025 Q1: 101 adverse event reports received by the FDA (0 death, 53 injury, 48 malfunction and 0 other).","value":101,"unit":"device adverse event reports received","reports":101,"deaths":0,"injuries":53,"malfunctions":48,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:JEQ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"JEQ","deviceName":"Toothbrush, Powered","specialty":"Dental","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Toothbrush, Powered (product code JEQ), 2025 Q1: 100 adverse event reports received by the FDA (0 death, 0 injury, 100 malfunction and 0 other).","value":100,"unit":"device adverse event reports received","reports":100,"deaths":0,"injuries":0,"malfunctions":100,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NIM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NIM","deviceName":"Stent, Carotid","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Stent, Carotid (product code NIM), 2025 Q1: 100 adverse event reports received by the FDA (3 death, 55 injury, 42 malfunction and 0 other).","value":100,"unit":"device adverse event reports received","reports":100,"deaths":3,"injuries":55,"malfunctions":42,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FFL:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FFL","deviceName":"Dislodger, Stone, Basket, Ureteral, Metal","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Dislodger, Stone, Basket, Ureteral, Metal (product code FFL), 2025 Q1: 99 adverse event reports received by the FDA (0 death, 9 injury, 90 malfunction and 0 other).","value":99,"unit":"device adverse event reports received","reports":99,"deaths":0,"injuries":9,"malfunctions":90,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MZF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MZF","deviceName":"Test, Hiv Detection","specialty":"Microbiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Test, Hiv Detection (product code MZF), 2025 Q1: 98 adverse event reports received by the FDA (0 death, 2 injury, 96 malfunction and 0 other).","value":98,"unit":"device adverse event reports received","reports":98,"deaths":0,"injuries":2,"malfunctions":96,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXC","deviceName":"Clamp, Vascular","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Clamp, Vascular (product code DXC), 2025 Q1: 96 adverse event reports received by the FDA (0 death, 17 injury, 79 malfunction and 0 other).","value":96,"unit":"device adverse event reports received","reports":96,"deaths":0,"injuries":17,"malfunctions":79,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSR","deviceName":"Pacemaker/Icd/Crt Non-Implanted Components","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Pacemaker/Icd/Crt Non-Implanted Components (product code OSR), 2025 Q1: 96 adverse event reports received by the FDA (0 death, 4 injury, 92 malfunction and 0 other).","value":96,"unit":"device adverse event reports received","reports":96,"deaths":0,"injuries":4,"malfunctions":92,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:GAP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"GAP","deviceName":"Suture, Nonabsorbable, Silk","specialty":"General, Plastic Surgery","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Suture, Nonabsorbable, Silk (product code GAP), 2025 Q1: 94 adverse event reports received by the FDA (0 death, 21 injury, 73 malfunction and 0 other).","value":94,"unit":"device adverse event reports received","reports":94,"deaths":0,"injuries":21,"malfunctions":73,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OCW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OCW","deviceName":"Endoscopic Tissue Approximation Device","specialty":"Gastroenterology, Urology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Endoscopic Tissue Approximation Device (product code OCW), 2025 Q1: 92 adverse event reports received by the FDA (0 death, 34 injury, 58 malfunction and 0 other).","value":92,"unit":"device adverse event reports received","reports":92,"deaths":0,"injuries":34,"malfunctions":58,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PYX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PYX","deviceName":"Temporary Non-Roller Type Right Heart Support Blood Pump","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Temporary Non-Roller Type Right Heart Support Blood Pump (product code PYX), 2025 Q1: 89 adverse event reports received by the FDA (17 death, 31 injury, 41 malfunction and 0 other).","value":89,"unit":"device adverse event reports received","reports":89,"deaths":17,"injuries":31,"malfunctions":41,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LRK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LRK","deviceName":"Device, Anti-Snoring","specialty":"Dental","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Device, Anti-Snoring (product code LRK), 2025 Q1: 83 adverse event reports received by the FDA (0 death, 5 injury, 78 malfunction and 0 other).","value":83,"unit":"device adverse event reports received","reports":83,"deaths":0,"injuries":5,"malfunctions":78,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:PZK:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"PZK","deviceName":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)","specialty":"Ophthalmic","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) (product code PZK), 2025 Q1: 71 adverse event reports received by the FDA (0 death, 71 injury, 0 malfunction and 0 other).","value":71,"unit":"device adverse event reports received","reports":71,"deaths":0,"injuries":71,"malfunctions":0,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:MDB:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"MDB","deviceName":"System, Blood Culturing","specialty":"Microbiology","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Blood Culturing (product code MDB), 2025 Q1: 66 adverse event reports received by the FDA (0 death, 2 injury, 64 malfunction and 0 other).","value":66,"unit":"device adverse event reports received","reports":66,"deaths":0,"injuries":2,"malfunctions":64,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NZU:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NZU","deviceName":"Collector, Urine, Powered, Non Indwelling Catheter","specialty":"Gastroenterology, Urology","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Collector, Urine, Powered, Non Indwelling Catheter (product code NZU), 2025 Q1: 63 adverse event reports received by the FDA (3 death, 49 injury, 11 malfunction and 0 other).","value":63,"unit":"device adverse event reports received","reports":63,"deaths":3,"injuries":49,"malfunctions":11,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:KGX:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"KGX","deviceName":"Tape And Bandage, Adhesive","specialty":"General Hospital","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Tape And Bandage, Adhesive (product code KGX), 2025 Q1: 62 adverse event reports received by the FDA (0 death, 52 injury, 9 malfunction and 1 other).","value":62,"unit":"device adverse event reports received","reports":62,"deaths":0,"injuries":52,"malfunctions":9,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DQA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DQA","deviceName":"Oximeter","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Oximeter (product code DQA), 2025 Q1: 61 adverse event reports received by the FDA (4 death, 2 injury, 55 malfunction and 0 other).","value":61,"unit":"device adverse event reports received","reports":61,"deaths":4,"injuries":2,"malfunctions":55,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NPW:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NPW","deviceName":"Percutaneously Delivered Prostheses And Tricuspid Valves","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Percutaneously Delivered Prostheses And Tricuspid Valves (product code NPW), 2025 Q1: 59 adverse event reports received by the FDA (3 death, 55 injury, 1 malfunction and 0 other).","value":59,"unit":"device adverse event reports received","reports":59,"deaths":3,"injuries":55,"malfunctions":1,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:DXN:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"DXN","deviceName":"System, Measurement, Blood-Pressure, Non-Invasive","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"System, Measurement, Blood-Pressure, Non-Invasive (product code DXN), 2025 Q1: 50 adverse event reports received by the FDA (0 death, 8 injury, 41 malfunction and 1 other).","value":50,"unit":"device adverse event reports received","reports":50,"deaths":0,"injuries":8,"malfunctions":41,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OOE:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OOE","deviceName":"Ophthalmic Femtosecond Laser","specialty":"Ophthalmic","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Ophthalmic Femtosecond Laser (product code OOE), 2025 Q1: 50 adverse event reports received by the FDA (0 death, 28 injury, 22 malfunction and 0 other).","value":50,"unit":"device adverse event reports received","reports":50,"deaths":0,"injuries":28,"malfunctions":22,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:QJP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"QJP","deviceName":"Catheter, Percutaneous, Neurovasculature","specialty":"Cardiovascular","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Catheter, Percutaneous, Neurovasculature (product code QJP), 2025 Q1: 50 adverse event reports received by the FDA (1 death, 23 injury, 26 malfunction and 0 other).","value":50,"unit":"device adverse event reports received","reports":50,"deaths":1,"injuries":23,"malfunctions":26,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:CAF:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"CAF","deviceName":"Nebulizer (Direct Patient Interface)","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Nebulizer (Direct Patient Interface) (product code CAF), 2025 Q1: 47 adverse event reports received by the FDA (8 death, 6 injury, 32 malfunction and 1 other).","value":47,"unit":"device adverse event reports received","reports":47,"deaths":8,"injuries":6,"malfunctions":32,"other":1,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:IOR:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"IOR","deviceName":"Wheelchair, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Wheelchair, Mechanical (product code IOR), 2025 Q1: 47 adverse event reports received by the FDA (0 death, 8 injury, 39 malfunction and 0 other).","value":47,"unit":"device adverse event reports received","reports":47,"deaths":0,"injuries":8,"malfunctions":39,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OSI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OSI","deviceName":"Bariatric Bed","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Bariatric Bed (product code OSI), 2025 Q1: 45 adverse event reports received by the FDA (0 death, 0 injury, 45 malfunction and 0 other).","value":45,"unit":"device adverse event reports received","reports":45,"deaths":0,"injuries":0,"malfunctions":45,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDP:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDP","deviceName":"Accessories, Implant, Dental, Endosseous","specialty":"Dental","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Accessories, Implant, Dental, Endosseous (product code NDP), 2025 Q1: 38 adverse event reports received by the FDA (0 death, 10 injury, 28 malfunction and 0 other).","value":38,"unit":"device adverse event reports received","reports":38,"deaths":0,"injuries":10,"malfunctions":28,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:BTI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"BTI","deviceName":"Compressor, Air, Portable","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Compressor, Air, Portable (product code BTI), 2025 Q1: 33 adverse event reports received by the FDA (4 death, 17 injury, 12 malfunction and 0 other).","value":33,"unit":"device adverse event reports received","reports":33,"deaths":4,"injuries":17,"malfunctions":12,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:FNM:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"FNM","deviceName":"Mattress, Air Flotation, Alternating Pressure","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Mattress, Air Flotation, Alternating Pressure (product code FNM), 2025 Q1: 32 adverse event reports received by the FDA (3 death, 10 injury, 19 malfunction and 0 other).","value":32,"unit":"device adverse event reports received","reports":32,"deaths":3,"injuries":10,"malfunctions":19,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NQO:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NQO","deviceName":"Prosthesis, Spinous Process Spacer/Plate","specialty":"Unknown","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Prosthesis, Spinous Process Spacer/Plate (product code NQO), 2025 Q1: 31 adverse event reports received by the FDA (0 death, 15 injury, 16 malfunction and 0 other).","value":31,"unit":"device adverse event reports received","reports":31,"deaths":0,"injuries":15,"malfunctions":16,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ITJ:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ITJ","deviceName":"Walker, Mechanical","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Walker, Mechanical (product code ITJ), 2025 Q1: 26 adverse event reports received by the FDA (0 death, 25 injury, 1 malfunction and 0 other).","value":26,"unit":"device adverse event reports received","reports":26,"deaths":0,"injuries":25,"malfunctions":1,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NSA:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NSA","deviceName":"Over-The-Counter Automated External Defibrillator","specialty":"Cardiovascular","deviceClass":"3","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Over-The-Counter Automated External Defibrillator (product code NSA), 2025 Q1: 26 adverse event reports received by the FDA (1 death, 0 injury, 25 malfunction and 0 other).","value":26,"unit":"device adverse event reports received","reports":26,"deaths":1,"injuries":0,"malfunctions":25,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:NDC:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"NDC","deviceName":"Calculator, Drug Dose","specialty":"Anesthesiology","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Calculator, Drug Dose (product code NDC), 2025 Q1: 20 adverse event reports received by the FDA (0 death, 1 injury, 19 malfunction and 0 other).","value":20,"unit":"device adverse event reports received","reports":20,"deaths":0,"injuries":1,"malfunctions":19,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:OJH:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"OJH","deviceName":"Orthopedic Tray","specialty":"General, Plastic Surgery","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Orthopedic Tray (product code OJH), 2025 Q1: 17 adverse event reports received by the FDA (0 death, 7 injury, 10 malfunction and 0 other).","value":17,"unit":"device adverse event reports received","reports":17,"deaths":0,"injuries":7,"malfunctions":10,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:ILS:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"ILS","deviceName":"Adaptor, Hygiene","specialty":"Physical Medicine","deviceClass":"1","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Adaptor, Hygiene (product code ILS), 2025 Q1: 13 adverse event reports received by the FDA (1 death, 12 injury, 0 malfunction and 0 other).","value":13,"unit":"device adverse event reports received","reports":13,"deaths":1,"injuries":12,"malfunctions":0,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"},{"id":"device-events:LLI:2025Q1","dataset":"device-events","jurisdiction":"US","level":"product-code","productCode":"LLI","deviceName":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use","specialty":"General Hospital","deviceClass":"2","quarter":"2025Q1","year":2025,"qtr":1,"periodStart":"2025-01-01","periodEnd":"2025-03-31","status":"P","text":"Bed, Therapeutic, Ac-Powered, Adjustable Home-Use (product code LLI), 2025 Q1: 8 adverse event reports received by the FDA (1 death, 4 injury, 3 malfunction and 0 other).","value":8,"unit":"device adverse event reports received","reports":8,"deaths":1,"injuries":4,"malfunctions":3,"other":0,"effectiveFrom":"2025-01-01","effectiveTo":"2025-03-31","sources":[{"label":"openFDA, device adverse event API (MAUDE)","url":"https://open.fda.gov/apis/device/event/","kind":"primary","accessed":"2026-10-29"},{"label":"openFDA license (CC0)","url":"https://open.fda.gov/license/","kind":"primary","accessed":"2026-10-29"}],"source":{"agency":"U.S. Food and Drug Administration (openFDA, Manufacturer and User Facility Device Experience)","url":"https://api.fda.gov/device/event.json","table":"device event count API (date_received, device.device_report_product_code, event_type)","release":"2026-10-13","accessed":"2026-10-29"},"flags":{"suppressed":false,"noise":false,"preliminary":false,"moe":null},"lastChecked":"2026-10-29","confidence":"high","confidenceBasis":"primary source; checked within 130 days; totals tie to the official file"}]}