Database of Adverse Event Notifications (DAEN) - medical devices

The Database of Adverse Event Notifications - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used in Australia.

The DAEN – medical devices does not contain information about adverse events related to medicines, which is instead accessed through the DAEN – medicines.

Search DAEN - medical devices

DAEN – medical devices: quick guide

• About the DAEN - medical devices
  Learn more about the Database and its limitations
• Consumer questions and answers: DAEN - medical devices
  Find answers to commonly asked questions about the DAEN - medical devices.
• Instructions for searching the DAEN - medical devices
  Learn how to generate and use your search results.
• About the search results: DAEN - medical devices
  Find information about the data contained in the two types of search results from the DAEN - medical devices.

Safety monitoring and adverse events

• Overview of how TGA manages medical device adverse event reports
  A look at TGA's medical device event report process.
• TGA safety monitoring of medical devices
  Find out how the TGA monitors medical devices and detects potential safety concerns in addition to receiving adverse event reports.
• Adverse event monitoring internationally
  Find out about other medicine and medical device regulators and where to access their adverse event databases.

Naming and grouping conventions

• Global Medical Device Nomenclature - GMDN
  Guidance on Global Medical Device Nomenclature (GMDN) Terms for medical devices (including in vitro diagnostic (IVD) medical devices).