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CATEGORY: SAFETY SURVEILLANCE
Serious Adverse Event
An adverse event that results in death, life-threatening condition, hospitalization, disability, congenital anomaly, or requires medical intervention to prevent permanent impairment. Serious adverse events trigger mandatory reporting to regulators.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
A serious adverse event (SAE) in the device context generally involves death, life-threatening illness/injury, permanent impairment, hospitalization, or medical/surgical intervention to prevent permanent damage—definitions vary slightly by jurisdiction and vigilance rules.
PROCESS / STEPS
- Triage complaints with seriousness criteria and causality assessment.
- Report within statutory clocks (e.g., FDA MDR timelines; EU vigilance timelines).
- Initiate risk assessment, CAPA, and field actions when trends or severity warrant.
- Document decisions even when not reportable.
EXAMPLES
- Unintended extended hospitalization after device malfunction typically meets seriousness criteria for evaluation as a reportable event.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Serious Adverse Event across 27 authorities in real time.
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