Reporting of incidents
An incident is an adverse event that leads or might have led to the endangering of health or death of a patient, user, or other person. Such an event may come to the distributor’s attention in the form of customer feedback, for example.
It is the responsibility of distributors to provide information on incidents immediately to the manufacturer so that the manufacturer can determine and investigate the causes of the incident. The distributor shall notify the manufacturer or authorised representative of any incidents it has become aware of that have been confirmed, or are suspected of, having resulted from a defect or shortcoming in a medical device.
Incidents can result, or be suspected of having resulted, from factors pertaining to the device such as:
- characteristics
- malfunction or deterioration in performance
- insufficient labelling
- any error or inadequacy in the information supplied by the manufacturer.
Devices shall be capable on being traced in the distribution chain for potential recalls and reporting of incidents.