{"@context":{"@language":"en","@vocab":"https://schema.org/","arrayShape":"cr:arrayShape","citeAs":"cr:citeAs","column":"cr:column","conformsTo":"dct:conformsTo","containedIn":"cr:containedIn","cr":"http://mlcommons.org/croissant/","rai":"http://mlcommons.org/croissant/RAI/","data":{"@id":"cr:data","@type":"@json"},"dataType":{"@id":"cr:dataType","@type":"@vocab"},"dct":"http://purl.org/dc/terms/","description":{"@container":"@language"},"equivalentProperty":"cr:equivalentProperty","examples":{"@id":"cr:examples","@type":"@json"},"extract":"cr:extract","field":"cr:field","fileProperty":"cr:fileProperty","fileObject":"cr:fileObject","fileSet":"cr:fileSet","format":"cr:format","includes":"cr:includes","isArray":"cr:isArray","isLiveDataset":"cr:isLiveDataset","jsonPath":"cr:jsonPath","key":"cr:key","md5":"cr:md5","name":{"@container":"@language"},"parentField":"cr:parentField","path":"cr:path","recordSet":"cr:recordSet","references":"cr:references","regex":"cr:regex","repeated":"cr:repeated","replace":"cr:replace","samplingRate":"cr:samplingRate","sc":"https://schema.org/","separator":"cr:separator","source":"cr:source","subField":"cr:subField","transform":"cr:transform"},"@type":"sc:Dataset","conformsTo":"http://mlcommons.org/croissant/1.1","name":"Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA)","description":"Adverse event reports the FDA received about medical devices, counted by device product code and calendar quarter from 2025 Q1: reports, deaths, injuries, malfunctions and other, for the 300 product codes with the most reports and for all devices together. Counted with the openFDA device event API (licence CC0); no report row, narrative, patient or manufacturer is ever read, only counts. Reports are filed up to weeks after an event and are driven by litigation and recalls as well as by harm, so a count is not an incidence rate.","url":"https://probativegrowth.com/data/device-events/","identifier":"https://doi.org/10.5281/zenodo.23752988","sameAs":["https://doi.org/10.5281/zenodo.23752988","https://doi.org/10.5281/zenodo.23752987","https://zenodo.org/records/23752988"],"version":"1.0.0","datePublished":"2026-10-29","dateModified":"2026-10-29","license":"https://creativecommons.org/licenses/by/4.0/","creator":{"@type":"sc:Organization","name":"Probative Growth","url":"https://probativegrowth.com"},"publisher":{"@type":"sc:Organization","name":"Probative Growth","url":"https://probativegrowth.com"},"citeAs":"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","keywords":["FDA MAUDE adverse event reports by product code","medical device adverse events by quarter","device injury reports openFDA","device recall injury reports trend","mass tort medical device reports","MDR counts by device type"],"inLanguage":"en","isAccessibleForFree":true,"isLiveDataset":false,"temporalCoverage":"2025-01-01/2026-09-30","spatialCoverage":{"@type":"sc:Place","name":"United States"},"distribution":[{"@type":"cr:FileObject","@id":"device-events.csv","name":"device-events.csv","description":"Every record, one row each (RFC 4180, UTF-8). Columns are described in README.txt.","contentUrl":"https://probativegrowth.com/data/v1/device-events/device-events.csv","contentSize":"1290786 B","encodingFormat":"text/csv","sha256":"47b5af1a4cd2213f9e19ab4c6d1e5d863a6d3031fe67f369b4c622fce76a3900"},{"@type":"cr:FileObject","@id":"device-events.json","name":"device-events.json","description":"Every record with its full sources, under a meta envelope (credit line, DOI, license).","contentUrl":"https://probativegrowth.com/data/v1/device-events/device-events.json","contentSize":"3069274 B","encodingFormat":"application/json","sha256":"c283d5d6c6f22220e8833e9bdd7ede00b3dfd17f02fb9803387e4032e63de499"}],"recordSet":[{"@type":"cr:RecordSet","@id":"device-events","name":"device-events","description":"The records of Medical device adverse event reports by product code and quarter (FDA MAUDE via openFDA), one per CSV row.","key":{"@id":"device-events/id"},"field":[{"@type":"cr:Field","@id":"device-events/id","name":"id","description":"Stable record id: dataset, place and period","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"id"}}},{"@type":"cr:Field","@id":"device-events/jurisdiction","name":"jurisdiction","description":"US for every record (the data are national)","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"jurisdiction"}}},{"@type":"cr:Field","@id":"device-events/level","name":"level","description":"product-code or us (all device product codes together)","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"level"}}},{"@type":"cr:Field","@id":"device-events/productCode","name":"productCode","description":"FDA's three-letter device product code (empty for the national record)","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"productCode"}}},{"@type":"cr:Field","@id":"device-events/deviceName","name":"deviceName","description":"Device name for the product code from the FDA classification database","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"deviceName"}}},{"@type":"cr:Field","@id":"device-events/specialty","name":"specialty","description":"FDA medical specialty of the product code","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"specialty"}}},{"@type":"cr:Field","@id":"device-events/deviceClass","name":"deviceClass","description":"FDA device class (1, 2, 3, or the code U/N where the FDA lists none)","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"deviceClass"}}},{"@type":"cr:Field","@id":"device-events/quarter","name":"quarter","description":"Calendar quarter of the date the FDA received the report, such as 2026Q2","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"quarter"}}},{"@type":"cr:Field","@id":"device-events/year","name":"year","description":"Calendar year of the quarter","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"year"}}},{"@type":"cr:Field","@id":"device-events/qtr","name":"qtr","description":"Quarter number 1 to 4","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"qtr"}}},{"@type":"cr:Field","@id":"device-events/periodStart","name":"periodStart","description":"First day of the quarter","dataType":"sc:Date","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"periodStart"}}},{"@type":"cr:Field","@id":"device-events/periodEnd","name":"periodEnd","description":"Last day of the quarter","dataType":"sc:Date","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"periodEnd"}}},{"@type":"cr:Field","@id":"device-events/status","name":"status","description":"P: counted from the primary source","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"status"}}},{"@type":"cr:Field","@id":"device-events/text","name":"text","description":"One plain sentence with the quarter's counts","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"text"}}},{"@type":"cr:Field","@id":"device-events/value","name":"value","description":"Same as reports","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"value"}}},{"@type":"cr:Field","@id":"device-events/unit","name":"unit","description":"What value counts","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"unit"}}},{"@type":"cr:Field","@id":"device-events/reports","name":"reports","description":"Adverse event reports (MDRs) the FDA received in the quarter for the product code; counted once per report that lists the code","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"reports"}}},{"@type":"cr:Field","@id":"device-events/deaths","name":"deaths","description":"Reports whose event type is Death","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"deaths"}}},{"@type":"cr:Field","@id":"device-events/injuries","name":"injuries","description":"Reports whose event type is Injury","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"injuries"}}},{"@type":"cr:Field","@id":"device-events/malfunctions","name":"malfunctions","description":"Reports whose event type is Malfunction","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"malfunctions"}}},{"@type":"cr:Field","@id":"device-events/other","name":"other","description":"reports less deaths, injuries and malfunctions: Other, No answer provided, and the few reports with no event type","dataType":"sc:Integer","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"other"}}},{"@type":"cr:Field","@id":"device-events/effectiveFrom","name":"effectiveFrom","description":"Same as periodStart","dataType":"sc:Date","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"effectiveFrom"}}},{"@type":"cr:Field","@id":"device-events/effectiveTo","name":"effectiveTo","description":"Same as periodEnd","dataType":"sc:Date","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"effectiveTo"}}},{"@type":"cr:Field","@id":"device-events/lastChecked","name":"lastChecked","description":"Date the openFDA API was last read","dataType":"sc:Date","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"lastChecked"}}},{"@type":"cr:Field","@id":"device-events/sourceLabels","name":"sourceLabels","description":"Sources, separated by \" | \"","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"sourceLabels"}}},{"@type":"cr:Field","@id":"device-events/sourceUrls","name":"sourceUrls","description":"Source URLs, in the same order","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"sourceUrls"}}},{"@type":"cr:Field","@id":"device-events/confidence","name":"confidence","description":"high, medium or low: computed from status, a second check, age against the refresh cadence and sampling error (rule: /data/#confidence)","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"confidence"}}},{"@type":"cr:Field","@id":"device-events/confidenceBasis","name":"confidenceBasis","description":"The reasons for the confidence level, in a short phrase","dataType":"sc:Text","source":{"fileObject":{"@id":"device-events.csv"},"extract":{"column":"confidenceBasis"}}}]}]}