The FDA MAUDE database is the agency's public record of medical device adverse event reports. This guide shows how to search it on the FDA site and through openFDA, how to work around its result limits, and what an MDR can and cannot tell you about a device.
MAUDE — the Manufacturer and User Facility Device Experience database — holds medical device reports (MDRs) of adverse events. Manufacturers, importers and device user facilities such as hospitals must report certain deaths, serious injuries and malfunctions; health care professionals, patients and consumers can report voluntarily through MedWatch, and those reports carry numbers beginning with "MW".
Each report names the device (brand, model, manufacturer, product code), the event type — death, serious injury, malfunction or other — the dates, and a narrative of what happened and what the manufacturer found. openFDA publishes more than 26 million of these records.
In March 2026 the FDA launched AEMS, its Adverse Event Monitoring System, to bring its adverse event databases together; FAERS has already moved into it and the FDA said device reports would follow. Until the MAUDE search is retired, it remains the place to search device reports, and openFDA keeps publishing them.
The FDA is explicit about the limits: MAUDE suffers from under-reporting, inaccuracies and "lack of verification that the device caused the reported event", and MDR data "is not intended to be used either to evaluate rates of adverse events". A report is a signal to investigate, not evidence of a defect.
Use the FDA search page for targeted lookups and openFDA when you need counts, trends or more than a few hundred reports.
On the MAUDE search page, enter a product code (it returns every device of that type, from every manufacturer) or a brand name, model number or manufacturer for one device. You can also search by PMA/510(k) number, report number or UDI device identifier.
Narrow to Death, Serious Injury or Malfunction, pick a product problem (for example "alarm, failure of"), and set the range for the date the FDA received the report. Choose up to 100 records per page.
Open each report to read the event description and the manufacturer's narrative. Check the reporter type and whether it is a summary report, which can bundle many events into one record.
Query api.fda.gov/device/event.json, for example search=device.device_report_product_code:DXY and count=event_type.exact, to get totals by event type in one call. Each call returns up to 1,000 records and skip goes to 25,000; a free API key raises the daily limit from 1,000 to 120,000 requests.
The web search covers the last ten years. For older reports, or any analysis of the whole database, download the FDA's MDR data files or the openFDA bulk files.
Where ClinicaLister holds MAUDE reports for a device, they appear in the device's detail view next to its 510(k) or PMA, GUDID identifiers and recalls, with event types summarised.
Reports are matched to a device record directly where possible and by product code otherwise. A product code covers a whole device category, so a product-code match can include other manufacturers' events — check the manufacturer on each report before treating it as the device's own history.
The same device record links to clinical trials sponsored by the device's applicant, so safety reports sit beside the trials studying the device.
Through the ClinicaLister MCP server, an AI assistant can pull the reports and safety signals held for a device without you writing openFDA queries.
50,800+
MAUDE reports held — a sample
3 weeks
reports received Oct 27 – Nov 17, 2025
26M+
reports in openFDA, for comparison
ClinicaLister holds a sample of MAUDE, not the full database: about 50,800 reports received by the FDA between October 27 and November 17, 2025, measured September 2026. For any device's complete report history, use the FDA MAUDE search or openFDA as described above.
No. The FDA states that reports may be incomplete or inaccurate and that a report does not show the device caused or contributed to the event. MAUDE is used to spot signals that need investigation.
No. MAUDE has no denominator — it does not know how many devices are in use — and events are under-reported. The FDA says MDR data is not intended for evaluating rates.
The FDA web search caps results at 500. Split your search into smaller date ranges, or use openFDA, which returns up to 1,000 records per call and supports counts across the whole result set.
The FDA search page is updated monthly with reports received through the end of the previous month. The openFDA device event endpoint is updated weekly.
No. It holds a sample of about 50,800 reports from late 2025, shown in device detail views. For complete history, search MAUDE or openFDA directly.
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