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類別: SAFETY SURVEILLANCE
MAUDE資料庫
FDA製造商和用戶設施器材體驗資料庫，包含醫療器材不良事件報告。MAUDE包括製造商、進口商和器材用戶設施的強制報告，以及消費者自願報告。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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
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