Medical device adverse event reporting by medical device users
Reporting form for use by medical device users
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. Reports originating in Australia should be sent to the Therapeutic Goods Administration and reports originating in New Zealand should be sent to the Ministry of Health.
A medical device is any material instrument, apparatus, machine implement, contrivance, implant etc including any component, part or accessory which is used in health care and includes in-vitro diagnostics.
There is a different form for use by medical device manufacturers or authorised representatives <http://www.tga.gov.au/docs/html/forms/iris_mdir.htm> for mandatory reporting of adverse events associated with a medical device.
Form
How to access a pdf or Microsoft Word document
This form is available in pdf format and Microsoft Word format. The pdf version can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.
- Medical device adverse event reporting form for use by medical device users (pdf,102kb)
- Medical device adverse event reporting form for use by medical device users (MS Word,151kb)
What should be reported?
Typical problems include deficiencies in labelling, instructions or packaging, defective components, performance failures, poor construction or design. Suggestions for rectifying the problem or improving product performance would be appreciated.
What happens to your report?
The report will be investigated and discussed with the manufacturer/supplier. You may be contacted for further information. If appropriate both Agencies will assess the issue and it may also be reported to other Health Authorities. If action is considered necessary it may involve any of the following:
- Recall - removal of goods from sale or use, or their correction, for reasons relating to safety, efficiency or quality.
- Safety Alert - urgent information to inform those responsible for the device, or affected by the problem.
- Report in a TGA News bulletin (a communication produced by the TGA and distributed in Australia and New Zealand to convey information on medical devices) or other appropriate journal(s).