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CATEGORY: SAFETY SURVEILLANCE
Adverse Event
Any undesirable clinical occurrence associated with the use of a medical device, whether or not caused by the device. Manufacturers must report certain adverse events to regulatory authorities within specified timeframes.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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 Adverse Event across 27 authorities in real time.
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