Medical device adverse event reporting by medical device manufacturers and sponsors
Reporting form for use by medical device manufacturers and sponsors
This form is to be used by medical device manufacturers or authorised representatives for mandatory reporting of adverse events associated with a medical device.
The act of reporting an event is not an admission of manufacturer, sponsor, user, or patient liability for the event or its consequences.
The sponsor is responsible for forwarding reports of all incidents to the manufacturer for assessment under the manufacturer's post-marketing system. It is possible that the sponsor will not have enough information to decide if the event should be reported to the TGA. In such a case, the sponsor should make reasonable efforts to obtain additional information to assist the manufacturer to make this decision. Where appropriate, the manufacturer should consult with the medical practitioners or other healthcare professionals involved, and do their utmost to retrieve the particular device. If there is any doubt about whether an incident report should be submitted, the report should be submitted. Although it is the manufacturer who must assess an incident, the sponsor will be held accountable for forwarding information concerning events to the manufacturer and then for forwarding the results of any analysis to the TGA.
There is a different form for use by medical device users <http://www.tga.gov.au/docs/html/forms/iris_udir.htm>, for example nurses, doctors, patients.
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.