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類別: SAFETY SURVEILLANCE
不良事件
與醫療器材使用相關的任何不良臨床事件，無論是否由器材引起。製造商必須在規定時間內向監管機構報告某些不良事件。
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
An adverse event is an undesirable clinical occurrence associated with device use—whether or not device-caused. Reportability depends on jurisdiction and seriousness.
PROCESS / STEPS
- Capture event details, device identifiers, and patient outcomes.
- Assess seriousness, causality, and reportability clocks.
- File MDR/vigilance reports as required; update risk files.
- Trend similar events for signals and CAPA.
EXAMPLES
- Malfunction without injury may still be reportable if recurrence could cause serious injury.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 不良事件 across 27 authorities in real time.
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