An adverse event is defined as an event which caused, led, or could have caused or could have led to death or serious injury of a patient or user of a medical device. Each regulatory regime adds its own caveats and definitions around this broad definition, to account for its local situation. Nevertheless the underlying feature is that all such events must be notified to the authority in the country where the event occurred. In some cases, these events must be notified to other authorities. In any case, in the ‘global village’, authorities advise one another of reported events.
It is of crucial importance that manufacturers have adequate adverse event reporting procedures. These form a key part of ‘maintaining approval.’