Searching the Database of Adverse Event Notifications for Medical Devices (DAEN)

1. Purpose and Overview

The Database of Adverse Event Notifications - medical devices (DAEN - medical devices) is a public resource provided by the Therapeutic Goods Administration (TGA) for searching reports of adverse events related to medical devices. The TGA checks reports for completeness and accuracy and analyzes them for patterns that may indicate potential safety issues. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

Reports are de-identified to protect privacy, with personal details removed. The database includes reports from 1 July 2012 up to three months prior to the date of access. Note that the report date does not necessarily reflect the actual date of the adverse event, as reports may be submitted years later, often in response to publicized events. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

2. Accessing the Database

Access the DAEN directly at: https://apps.tga.gov.au/prod/DEVICES/daen-entry.aspx. Select "medical devices" as the search category to begin. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

3. Basic Search Process

1. Select Date Range: Choose start and end dates (year, month, day). Ensure the "to" date is after the "from" date.
2. Enter Search Terms: Type at least the first three characters of the trade name, sponsor name, manufacturer name, Global Medical Device Nomenclature (GMDN) term (e.g., 'hip', 'pump'), or Australian Register of Therapeutic Goods (ARTG) number. A filtered list of matching options appears, ordered by relevance, showing manufacturer, trade name (with GMDN term in brackets), and other details.
3. Refine and Select: Enter additional characters to further filter the list. Tick the boxes to select desired medical devices.
   Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

The selection is limited to medical devices contained in the DAEN. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

4. Search Options and Best Practices

• Trade name and ARTG number: Best for specific device searches. If spelling is uncertain, enter the first few letters and browse results.
• Sponsor and manufacturer: Suitable for broader or general searches when the trade name is unknown.
• GMDN term: Ideal for searching by device type (e.g., 'hip', 'pump'), which may cover devices from different companies.
  Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

5. Advanced Search Options

After selecting a medical device and date range, access advanced search to restrict results by ISO event type codes (based on ISO/TS 19218-1:2011, e.g., codes for Activation, Positioning or Separation; Computer Hardware; Mechanical issues; Use Error). Only ISO event types recorded for the selected devices and date range are shown. Advanced fields are optional and help narrow results. Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

6. Viewing and Interpreting Results

Results appear in two tabs:

• Medical Device Summary: Displays general details of the reported medical device(s) involved.
• List of Reports: Provides further information on the device(s) and a de-identified description of the adverse event for each report.
  Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

7. Important Notes and Limitations

• Data is current up to three months before access.
• Searches are restricted to available data fields and devices in the DAEN.
• For GMDN term details, refer to related TGA resources.
• For ARTG information, consult the ARTG database.
  Source: https://www.tga.gov.au/safety/adverse-events/medical-device-adverse-events/how-search-medical-devices-database-adverse-event-notifications

This guide helps users effectively search for adverse event information on medical devices to support awareness of reported issues. Related resources include advanced search details and ISO event type codes information.