Serious injury

Deaths and serious injuries that a device may have caused or contributed to have to be reported to FDA as Medical Device Reports. Temporary injuries that need no intervention generally fall outside it, although a malfunction that could lead to a serious injury can still be reportable.

Serious injury means an injury or illness that: (1) Is life-threatening, (2) Results in permanent impairment of a body function or permanent damage to a body structure, or (3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.

21 CFR, 803.3

injury or illness that: a) is life threatening, b) results in permanent impairment of a body function or permanent damage to a body structure, or c) necessitates medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure NOTE Permanent impairment means an irreversible impairment or damage to a body structure or function excluding trivial impairment or damage.

IEC 62304:2006+AMD1:2015, clause 3.23