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CATEGORY: SAFETY SURVEILLANCE
MAUDE Database
The FDA Manufacturer and User Facility Device Experience database containing medical device adverse event reports. MAUDE includes mandatory reports from manufacturers, importers, and device user facilities, as well as voluntary consumer reports.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
MAUDE is the FDA’s public database of medical device adverse event reports (MDRs). RA, quality, and post-market teams use it for signal detection, competitive surveillance, and complaint trending. Note: FDA is migrating device AE workflows toward AEMS (2026).
PROCESS / STEPS
- Search by brand, manufacturer, product code, or free text on the FDA MAUDE interface—or use openFDA device/event APIs for bulk analysis.
- Filter by date received, event type (death, injury, malfunction), and device characteristics.
- Read narrative fields carefully; codes alone often miss root-cause context.
- Correlate with recalls/enforcement reports and your own complaint files.
- For ongoing monitoring, automate queries rather than one-off manual searches (MedFlux aggregates signals across regulators).
EXAMPLES
- Investigating recurring malfunctions for a product code used by multiple competitors.
- Supporting clinical evaluation literature with public AE patterns (with caveats on under/over-reporting).
COMMON MISTAKES
- Treating report counts as incidence rates without exposure denominators.
- Ignoring that MAUDE search UI caps results; large pulls need openFDA/downloads.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to MAUDE Database across 27 authorities in real time.
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