Report a problem with a medical device

Users of medical devices are encouraged to report problems that have caused, or could cause, harm to patients, caregivers or others. Investigations of medical device incidents can lead to actions such as product recalls, safety alerts, product improvement, user education and compliance testing.

The Medical Device Incident Reporting and Investigation Scheme (IRIS) is responsible for the management of all reports of adverse events or problems associated with medical devices that are reported to the TGA.

Typical problems with medical devices include:

  • deficiencies in labelling, instructions or packaging
  • defective components
  • performance failures
  • poor construction or design

Reporting adverse events