Safety monitoring: Medical devices

Medical devices range from a bandage that you would put on a scratch to high risk 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.

Users of medical devices are encouraged to report problems that have caused, or could cause, harm to patients, carers or others. Investigations of medical device incidents can lead to actions such as product recalls, safety alerts, product improvement, user education and compliance testing. 

Reporting medical device adverse events

Medical device consumers: report problems or incidents through the consumer online Medical Device Incident Report form.

Health professionals: report problems or incidents online through the health professional online Medical Device Incident Report form.

Sponsors and manufacturers: report using the TGA's online reporting system.

More information 

• Database of Adverse Event Notifications (DAEN)
• Medical devices safety
• Reporting adverse events
• Overview of how TGA manages medical device adverse event reports
• Post-market review of face masks: Cancelled ARTG entries