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:
Report if the patient's death is suspected
as being a direct outcome of the adverse event.
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 which permits uncontrolled
free flow resulting in excessive drug dosing.
(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.
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.
accident due to drug-induced hypercoagulability;
toxicity; peripheral neuropathy.
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
to Prevent Permanent Impairment or Damage
Report if you suspect that the use of
a medical product may result in a condition which 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