Important information on the Database of Adverse Event Notifications - medical devices
- An adverse event report does not mean that the medical device is the cause of the adverse event.
- If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible.
- The search results can not be used to determine the incidence or likelihood of an adverse event occurring.
About the Database of Adverse Event Notifications (DAEN) - medical devices
- The DAEN - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used in Australia since 1 July 2012.
- The DAEN - medical devices does not contain all known safety information about a particular medical device. Please do not make an assessment about the safety of a medical device based on the information in the DAEN - medical devices.
The TGA medical device safety monitoring program
For information and guidance about DAEN – medical devices, including guidance and frequently asked questions, visit the DAEN medical device safety monitoring page on the TGA website.
Other useful sources of information on Australian medical devices
More information about a medical device is generally available in the instructions for use and/or on the labelling and packaging of a medical device.
Your health professional can also provide help and assistance on how to use medical devices.
Information on a range of health and wellbeing topics including medical devices is available from healthinsite
About the release of this information
While reasonable care is taken to ensure that the information is an accurate record of the adverse events reported to the TGA, the TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.
To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on this information.
Copyright restrictions apply to the DAEN - medical devices.
- An adverse event report does not mean that the medical device is the cause of the adverse event.
- If you are experiencing an adverse event, or think you may be experiencing one, please seek advice from a health professional as soon as possible.
- The search results can not be used to determine the incidence or likelihood of an adverse event occurring.
- The TGA is aware of potential inaccuracies affecting a small number of medical device incident reports. Specifically, the sponsor name referenced in the incident report may be incorrect. The TGA is investigating these reports in order to resolve the issue as soon as possible.
The Database of Adverse Event Notifications (DAEN) – medical devices allows you to search adverse event reports for medical devices received by the TGA since 1 July 2012. These reports come from a wide range of sources, including members of the public, medical practitioners, nurses, other health professionals and the therapeutic goods industry.
People who experienced an adverse event cannot be identified, and maintaining their privacy has been of paramount importance to the TGA.
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More about the databaseThe DAEN - medical devices is being made available to the members of the public as part of TGA initiatives to be more transparent about its activities. It is also hoped that access to this information will support the appropriate use of medical devices and encourage reporting of adverse events.
The DAEN - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used in Australia. The report of an adverse event in relation to a medical device should not be taken to mean that the medical device is the cause of the adverse event.
The DAEN - medical devices does not contain all known safety information concerning a medical device, and an assessment of the safety of a medical device cannot be made based only on this information. For information and guidance about DAEN – medical devices, including guidance and frequently asked questions, visit the DAEN medical device safety monitoring page on the TGA website.
Search the DAEN - medical devices
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You must select one or more medical devices and a date range.