Medical-device postmarket surveillance
How to Search the FDA MAUDE Database Without Misreading It
Search FDA MAUDE medical-device reports by product code and time window while preserving reporting, denominator, causation, and comparability limitations.
Direct answer
Search MAUDE by product code, manufacturer, device identifiers, event type, and time window, then inspect the underlying reports. Treat counts as reporting signals—not adverse-event rates, incidence, causation, or proof that one device is safer than another.
Explore MAUDE and recall signals →Choose a stable device identity
Trade names, manufacturer names, and narrative text can vary. Product code is often the most stable starting point for a cohort, while brand and manufacturer searches help find device-specific records.
Document the exact filters used: product code, date range, event type, manufacturer aliases, and whether follow-up reports are included. Without the query definition, a count cannot be reproduced or compared over time.
- Start with product code for category-level monitoring.
- Add manufacturer and brand aliases for device-level review.
- Inspect narratives and report dates, not only aggregate counts.
- Keep recalls and clearance history as separate evidence streams.
Do not turn reports into rates
FDA explicitly warns that MAUDE cannot be used by itself to estimate incidence, prevalence, event rates, changes in rates, or causal relationships. The database is a passive reporting system with under-reporting, incomplete or inaccurate reports, uncertain device-use denominators, and unverified causation.
A higher count can reflect reporting practices, installed base, publicity, coding, follow-up submissions, or true differences. Without exposure denominators and additional investigation, those explanations cannot be separated.
Use MAUDE for signal triage
A defensible workflow asks whether reporting patterns changed, which event narratives recur, and what corroborating evidence exists. It does not label a device unsafe from a count alone.
Constat presents product-code trends with explicit denominators and limitations, then links the signal to recalls and device evidence. The result is a research queue for human review, not a safety conclusion.
Questions researchers ask
Can MAUDE show which medical device is safest?
No. MAUDE lacks reliable usage denominators and has reporting and verification limitations, so raw report counts cannot establish comparative safety.
Does a MAUDE report prove the device caused an event?
No. FDA states that submitting a report does not necessarily establish that a device caused or contributed to the event.
What is MAUDE useful for?
It is useful for finding reports, reviewing narratives, monitoring reporting patterns, and prioritizing signals for investigation alongside recalls and other evidence.