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Last Updated Thursday, July 31 2014
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Serious Adverse Event (SAE)



According to FDA, an adverse event associated with the use of a medical product is considered serious and should be reported to the agency when the patient outcome results in: death, life-threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or intervention to prevent permanent impairment or damage.


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