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Medical device adverse events

Find out how to report and search for medical device adverse events.

This page is in Beta testing. We welcome your feedback and suggestions as we look to improve this page.

About medical device adverse events

Medical devices can have significant benefits. However, like all therapeutic goods sometimes things can go wrong. Medical devices range from a bandage that you would put on a scratch to products such as pacemakers that are implanted in your body. Typical problems with medical devices include:

  • deficiencies in labelling, instructions or packaging
  • defective components
  • performance failures
  • poor construction or design.

It’s important to report serious problems like death, lasting harm, or conditions needing urgent treatment. You should also report 'near misses', when someone almost got seriously hurt but didn’t. It may be that a health professional acted in time to prevent an adverse event. Find out more:

Report an adverse event

Anyone can make a report. You can submit a report for yourself or on behalf of another person. 

It’s easy to report an adverse effect online. There are different steps for consumers, health professionals and sponsors.

We encourage you to report adverse effects even if you’re not 100% sure the product caused them. You don't need to be certain, just suspicious!

Give as much information as you can. 

For consumers 

You can make a report online through the Medical Device Incident Report system. 

For health professionals

You can make a report online through the Medical Device Incident Report system for health professionals. 

For industry

You can make a report online through the Medical Device Incident Reporting system portal for industry. Find out more before you report: 

Get support

If you need help to make a report, email iris@health.gov.au.

How we manage adverse event reports

We receive and manage medical device adverse event reports through two databases:

  • medical device incident reports are recorded in the Incident Reporting and Investigation Scheme (IRIS) database.
  • healthcare facilities report on medical devices using our medical device Adverse Signal Detection and Event Reporting (ASDER) system.

See How we manage medical device adverse event reports for further information. 

Search adverse events for medical devices

You can search for adverse events about medical devices in our 'DAEN Medical Devices' database. Below you will find information on how to search the database.

Search DAEN Medical Devices- external site

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