An adverse event is any undesirable experience associated with the use of a medical product in a patient.
When is an adverse event considered serious?
The patient's death is suspected as being a direct outcome of the adverse event.
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 which permits uncontrolled free flow resulting in excessive drug dosing
Hospitalization (initial or prolonged)
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
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
There are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.