How to report problems and side effects related to medical devices

Consumers and healthcare professionals are strongly encouraged to report adverse events related to medical devices directly to the TGA via the online medical device reporting form.

All reports made through the online medical device reporting form are assessed and entered into the TGA’s Incident Reporting and Investigation Scheme (IRIS).

The Database of Adverse Event Notifications (DAEN) contains information from reports of adverse events in relation to medical devices received by the TGA since 1 July 2012.