Medical Device Adverse Event Reporting

Medical devices play an important role in the diagnosis, treatment, monitoring or prevention of an illness or disability. While most devices work as intended, problems can sometimes occur. Reporting issues with a medical device helps improve patient safety and ensures medical devices used in Australia continue to meet national safety and quality standards.

If you suspect a medical device is causing harm, malfunctioning, or not performing as intended you are encouraged to:

1. Raise the issue with your healthcare professional, and
2. Report the issue to the Therapeutic Goods Administration (TGA) Medical Device Incident Reports (external site)

This fact sheet (PDF) explains what types of issues should be reported and how patients, carers and consumers can recognise and report medical device problems to the TGA