An adverse event that

(A) results in:

- death;

- a life-threatening experience;

- inpatient hospitalization;

- a persistent or significant disability or incapacity;

- a congenital anomaly or birth defect;

- an infection;

- significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual;

(B) requires, based on reasonable medical judgment, a medical or surgical

intervention to prevent an outcome described in (A) above.

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