Overview of adverse event reporting for medical devices

Adverse events are unexpected problems that happen when using a medical device, medicine or vaccine. They can include side effects or issues that cause harm, or that could have caused harm. 

Examples of adverse events include: 

• a medical device not working properly and putting someone at risk
• a lab test showing something unusual.

Sometimes, these events aren’t caused by the product itself. They might happen because of how it’s used or how different products interact. Just because an adverse event happens, doesn’t mean the product is faulty. 

Our safety monitoring program relies on reports from consumers, health professionals and medical device companies.

Every report counts. One report may not be enough to determine if a therapeutic good caused an adverse reaction, but all reports help us build a picture of a product's safety profile.

Our work is based on applying scientific and clinical expertise to decision making. We decide whether the benefits to consumers outweigh any risks associated with the use of medicines, medical devices and other therapeutic goods.

Medical devices range from a bandage that you would put on a scratch to products such as pacemakers that are implanted in your body. Other examples include:

• artificial hips
• blood pressure monitors
• breast implants
• catheters
• condoms
• lubricating eyedrops
• MRI scanners
• orthodontics, such as braces and dental aligners
• syringes
• tongue depressors.

Typical problems with medical devices include:

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

Adverse events we need to know about for medical devices

You can report any medical device incident. It’s especially important to report problems that may have caused death or serious harm, including: 

• a life-threatening illness or injury
• permanent impairment of a body function
• permanent damage to a body structure
• a condition that needed medical or surgical treatment to prevent permanent harm.

We also need to know about all ‘near adverse events’ that might have led to death or serious injury if someone hadn’t intervened. For example, if a healthcare worker stepped in just in time to prevent the adverse event from occurring. 

A near adverse event is when:

• something happens involving a medical device and
• if it happened again, and had not been caught, it could cause serious harm or even death.
   

Anyone can make a report. You can submit a report for yourself or on behalf of another person. There are different steps for consumers, health professionals, medical device sponsors and manufacturers: 

• As a consumer, you can make a report online through the Medical Device Incident Report system.
• As a healthcare professional, you can make a report online through the Medical Device Incident Report system for healthcare professionals.
• As a sponsor or manufacturer, you can make a report online through the Medical Device Incident Reporting system portal. See Report a medical device incident - for sponsors and manufacturers to get started.

We encourage you to report an adverse event even if you’re not 100% sure the medical device caused it. You don't need to be certain, just suspicious!

Please give us as much information as possible in your report. The more details you can give, the better picture we can build about a product’s safety.

Patient details

• Gender
• Age

Reporter details

• Name
• Contact details (name, address, phone number)

Product details

• Name of product
• What the product was taken or used for
• How the product was taken or used (swallowed, injected or applied; dose; how often)

Adverse event or side effect details

• What happened?
• Did you/they receive treatment for the side effect?
• Have you/they recovered?

We ask for contact details from people making reports so that we can ask for more information about suspected adverse events if needed. A name is required with an option for us to anonymise information.

We collect a variety of personal information to process these reports.

Information about we handle personal information under the Privacy Act 1988 is in the Privacy section of our website.

If you're a sponsor or healthcare facility, learn your obligations for medical device adverse reporting at: Obligations to report an adverse event for medical devices.