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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

• Reporting medical device adverse incidents
  Everyone is encouraged to report any adverse event or potential adverse event with a medical device
• Report a medical device adverse event (medical device user)
  Medical device users (clinicians, patients or their relatives, etc) should use this form to report any suspected problems with a medical device which has or may present a health hazard
• Medical device incident reporting & investigation scheme (IRIS)
  The IRIS is responsible for the management of all reports of adverse events or problems associated with medical devices that are reported to the TGA