Medical device adverse events
Find out how to report and search for medical device adverse events.
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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:
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Overview of adverse event reporting for medical devices
Learn how everyone can play an important role in monitoring the safety of medical devices in Australia. -
How we manage your medical device adverse event report
Find out what happens after you submit a report and actions we can take.
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:
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Report a medical device incident - for sponsors and manufacturers
Industry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system. -
Obligations to report an adverse event for medical devices
Information on how to report an adverse event or concern about a medical device.
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.
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About the Database of Adverse Event Notifications (DAEN): medical devices
The medical devices DAEN is our online database that contains information from suspected adverse events reported to us for medical devices. -
How to search the Database of Adverse Event Notifications (DAEN): medical devices
Find out how to search the DAEN for medical devices.