What is a serious adverse event?

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is SERIOUS and should be reported when the patient outcome is:

Death

Report if the patient’s death is suspected as being a direct outcome of the adverse event.

Life-Threatening

Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient’s death.

Examples: Pacemaker failure, gastrointestinal hemorrhage, bone marrow suppression, infusion pump failure that permits uncontrolled free flow resulting in excessive drug dosing.

Hospitalization (initial or prolonged)

Report if admission to the hospital or prolongation of a hospital stay results because of the adverse event.

Examples: Anaphylaxis, pseudomembranous colitis, or bleeding causing or prolonging hospitalization.

Disability

Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities, or quality of life.

Examples: Cerebrovascular accident due to drug-induced hypercoagulability, toxicity, peripheral neuropathy.

Congenital Anomaly

Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

Examples: Vaginal cancer in female offspring from diethylstilbestrol during pregnancy; malformation in the offspring caused by thalidomide.

Requires Intervention to Prevent Permanent Impairment or Damage

Report if you suspect that the use of a medical product resulted in a condition that required medical or surgical intervention to preclude permanent impairment or damage to a patient.

Examples: Acetaminophen overdose-induced hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage; burns from radiation equipment requiring drug therapy; breakage of a screw requiring replacement of hardware to prevent malunion of a fractured long bone.

Source: Food and Drug Administration, Safety Information and Adverse Event Reporting Program, Rockville, MD.