Report a medical device adverse event (medical device user)

A medical device is any instrument, apparatus, appliance, material or implant that is used to diagnose, treat or prevent a medical condition and includes in vitro diagnostic tests such as blood glucose tests.

Medical device users (clinicians, patients or their relatives, etc.) should use this form to report any actual or suspected problems with a medical device which has, or may present, a health hazard. There is a different form for use by medical device manufacturers or authorised representatives for mandatory reporting of adverse events associated with a medical device.

On this page: What should be reported? | What happens to your report? | Forms | Sending medical devices to the TGA for testing

What should be reported?

Typical problems include deficiencies in labelling, instructions or packaging, defective components, performance failures, poor construction or design. Your 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 by the TGA for further information. If action is considered necessary by the TGA it may involve any of the following:

1. Recall - removal of goods from sale or use, or their correction, for reasons relating to safety, performance or quality.
2. Safety Alert - distribution of urgent information to inform those responsible for the device, or affected by the problem.
3. An alert or advisory on the TGA website.

Forms

Complete the online form to report a problem with a medical device.

Issues experienced in completing the online medical device adverse event reporting form should be directed via email to iris@tga.gov.au or phone 1800 809 361.

Sending medical devices to the TGA for testing

If a medical device is involved in an adverse event the TGA may be interested in examining it.

After submitting a report to the Incident Reporting and Investigation Scheme (IRIS) please wait until a representative from the TGA has contacted you to say whether the device should be sent to the TGA or the sponsor/manufacturer.

About submitting devices

The TGA:

• can test or visually inspect all medical devices, and
• accepts devices that are contaminated.

There are some devices for which the TGA cannot do a complete examination, this is usually because the equipment available for some of the tests is specific to the device manufacturer. The TGA will test or examine the device, and if granted permission by the reporter, the device will be sent to the manufacturer for further testing.

As part of its investigation of the adverse event report the TGA analyses all manufacturer testing.

When sending medical devices to the TGA please follow these steps

1. Clean the device as much as possible without destroying any evidence that you feel contributed to the adverse event.
2. All devices should be doubled packaged in plastic bags designed for transport of bio-hazardous objects. The outer package must be clearly labelled with the contents and warnings if the device is contaminated.
3. If the device has sharp edges or components such as suture needles, please pack these items into a sealed plastic container in addition to the plastic bags.
4. Medical devices should be sent to:
   • The Coordinator Incident Report Investigation Scheme
     TGA
     Medical Devices Branch
     27 Scherger Drive
     Fairbairn ACT 2609
5. If you require assistance with transporting medical devices, please contact the coordinator on 1800 809 361.