The event is SERIOUS and should be reported when the patient outcome is:

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

Life-threatening: 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.

Hospitalization (initial or prolonged): admission to the hospital or prolonging of a hospital stay results because of the adverse event.

Disability: the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body functions/structure, physical activities or quality of life.

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

Requires intervention or prevent permanent impairment or damage: 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.