MAUDE Database

What is the MAUDE database?

MAUDE houses the reports the FDA receives under medical device reporting: mandatory reports from manufacturers, importers and device user facilities, and voluntary reports from clinicians and patients via MedWatch. Records are searchable by device, brand, manufacturer, event type and date, and the FDA updates the public file monthly.

What is MAUDE used for?

Manufacturers monitor MAUDE for signals about their own and competitor devices; submitters study it to understand the real-world failure modes of a device category before writing risk documentation; litigators and journalists mine it. For a company preparing a U.S. submission, the reports filed against predicate and competitor devices are among the cheapest available windows into what actually goes wrong in the field.

What are MAUDE's limitations?

The FDA itself is explicit: passive surveillance data cannot establish incidence rates or prove causation. Reporting is incomplete and uneven, one event can generate multiple reports, report quality varies, and denominators — how many devices are in use — are absent. Counting MAUDE reports and calling the result a failure rate is the classic misuse.

Does a MAUDE report mean a device is defective?

No. A report reflects that an event was reported in connection with a device, not an FDA finding of fault. The database coexists with the FDA's other surveillance tools — recalls, inspections and signal evaluation — and a spike in reports is a starting point for investigation, not a conclusion. Manufacturers active in the United States typically wire MAUDE monitoring into their post-market surveillance procedures.