MAUDE
Manufacturer and User Facility Device Experience — the FDA adverse-event reporting database. Manufacturers must submit MDRs (Medical Device Reports) for serious events (death, serious injury, malfunction with potential to cause harm).
Why it matters to buyers: Due diligence — check MAUDE by device for patterns before buying used. Reports are searchable on FDA.gov.
Why it matters to engineers: Report counts alone are misleading — field size matters. Look at cluster types (mechanical, electrical, software) and outcome severity. Underreporting bias is real.