Reporting medical device problems

The TGA's Incident Reporting and Investigation Scheme (IRIS) is focused on adverse events or incidents related to the use of medical devices.

Investigations of reports of adverse events or potential adverse events from medical device users (including patients and caregivers), sponsors and manufacturers can lead to actions such as product recalls, safety alerts, product improvement, user education and compliance testing.

Online forms are available for reporting medical device adverse events.

The online reporting forms are:

user friendly
contain instructional text
support the attachment of electronic documentation
provide a TGA reference (DIR) number upon submission

Medical device users and sponsors/manufacturers are encouraged to complete an online reporting form on the TGA website as an alternative to downloading and completing a Microsoft Word or PDF form and then submitting via email, fax or mail.

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
Report a medical device adverse event (sponsor/manufacturer)
This form is to be used by medical device manufacturers or authorised representatives for mandatory reporting of adverse events associated with a medical device
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

Web page last updated: Monday, 5 March 2012

URL: http://www.tga.gov.au/safety/problem-device.htm

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