{"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/quarters/2025Q1.json","humanUrl":"https://probativegrowth.com/data/device-events/","statusCodes":{"P":"primary source","S":"secondary source","D":"ABA model default","U":"open question"}},"key":"2025Q1","records":[{"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: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"}]}