MAUDE, the FDA’s Manufacturer and User Facility Device Experience database, holds the medical device reports that manufacturers, importers and user facilities are required to file. For anyone in regulatory affairs, quality or post-market surveillance, it is the main public record of how devices fail in use.
This guide covers who reports, how to search it, where the data misleads and how to build a surveillance routine around it.
What is the MAUDE database?
MAUDE is a public database maintained by the FDA’s Center for Devices and Radiological Health. It contains medical device reports (MDRs) submitted under 21 CFR Part 803, covering deaths, serious injuries and malfunctions.
It has collected reports since 1991 and holds millions of records. Each has structured fields, such as device name, product code, event type and patient outcome, plus a free-text narrative describing what happened.
Who reports to MAUDE?
Manufacturers report when they become aware that a device may have caused or contributed to a death or serious injury, or malfunctioned in a way likely to do so if it recurred. Under 21 CFR 803.50 they have 30 calendar days, or 5 days for events requiring remedial action.
User facilities, mainly hospitals and nursing homes, report device-related deaths to the FDA and the manufacturer within 10 working days. They report serious injuries to the manufacturer, or to the FDA if the manufacturer is unknown, in the same window.
Importers report deaths and serious injuries to the FDA and the manufacturer within 30 calendar days.
Voluntary reports from clinicians and patients also appear in MAUDE.
How to search MAUDE
The MAUDE web interface (accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) searches by product class, event type, manufacturer, date range and keyword. It is slow, paginated and has no bulk export.
The openFDA API (open.fda.gov) provides MAUDE data as JSON, with complex queries and date filters. It refreshes on its own schedule, so results can differ from the web interface. The limit is 240 requests a minute with an API key, which is enough for most surveillance work.
Bulk download files are pipe-delimited text files updated quarterly. They suit historical analysis or a local database.
For ongoing surveillance, the API is the practical choice.
MAUDE limitations to plan around
Reports arrive late. A report can take 4 to 8 weeks to appear after submission, and some take longer. MAUDE is a lagging indicator and should not be the only source for emerging signals.
Duplicates are common. When a manufacturer and a user facility report the same event, two records appear with different MDR report numbers. The FDA does not systematically deduplicate them, so raw counts can overstate the number of events.
Narrative quality varies. Some narratives give a timeline, patient details and a root cause analysis. Others say “Device malfunctioned.”
A report is not proof of causation. It records an event associated with a device. The FDA states that MAUDE data alone cannot establish incidence rates or causal conclusions.
Product codes are inconsistent. Manufacturers classify similar devices under different codes, and codes change. Check that your monitoring covers every relevant one.
Using MAUDE for post-market surveillance
Set a cadence and document it. Choose a search frequency that fits the device’s risk and how often the sources update, and record it in your post-market surveillance plan.
Monitor the product code, not only your brand. The whole code gives early warning of class-wide issues and a benchmark for your own device. I wrote more about that in why most competitor monitoring programs miss what matters.
Search the narratives by keyword. Combine product code filters with terms for the failure modes in your risk management file.
Track trends, not single reports. Any one report may be an outlier, a duplicate or poorly documented. The value is in patterns: a failure mode reported more often, a new type of injury or a problem tied to one lot or model.
Document the method. Your plan should describe how you search, how often and how results are reviewed and escalated. FDA inspectors and EU MDR Article 83 both expect it.
Why manual MAUDE searching runs out
One product code can generate hundreds of new reports a month. Reading and classifying the narratives, finding duplicates, tracking trends and documenting it all can consume a full-time role for a modest portfolio. I covered where that breaks in manual MAUDE surveillance doesn’t scale.
DeviceWatch automates the mechanical part. It ingests new reports from the openFDA API each week and uses AI to turn each narrative into a structured summary. A regulatory professional still reviews and acknowledges every one.
MAUDE and AEMS
The FDA launched its Adverse Event Monitoring System (AEMS) in March 2026 with drug data from FAERS, and has said MAUDE data will become available there. As of late October 2026, openFDA’s device adverse event documentation still names MAUDE as its source and refreshes weekly, so existing searches and pipelines work as before.
The current state is in what FDA AEMS means for MAUDE searches.