FDA Reportable Event Policy Term Definition

an event where a device has the potential to cause or contribute to a serious injury, serious illness or death of a patient or employee. This event may include equipment malfunctions and/or user errors. Reporting to the FDA is required within ten working days. These same reportable events may also fall within the Adverse Event or Sentinel Event policies. A serious event is defined as one in which 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 continued use of the product would result in the patient’s death.
  • Hospitalization (initial or prolonged) – if admission to the hospital or prolongation of a hospital stay results because of the adverse event.
  • Disability – 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.
  • Congenital anomaly – if 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 to prevent permanent impairment or damage – if the use of a medical product results in a condition which requires medical or surgical intervention to preclude permanent impairment or damage to a patient.