The NCAR Exchange Program will be used to exchange information relating to significant concerns or potential trends that individual authorities have observed in their jurisdictions but have not yet resulted in recalls or Field Safety Corrective Actions (FSCAs).
Events Leading or Highly Likely to Lead to Unanticipated
Public Health Threat
Reportable events, associated with a medical device that have led or are highly likely to lead to
unanticipated serious public health threat and fulfill the following criteria:
• Death of a patient, user or other person.
• Serious injury of a patient, user or other person.
• No death or serious injury occurred but the event might lead to death or serious injury of a patient, user or other person if the event recurs. Some jurisdictions refer to these events as near incidents…
