Revised: 29 August 2013
Overview of how Medsafe manages medical device adverse event reports
Medsafe receives adverse event reports of medical devices from users, healthcare professionals and the
medical device industry.
The reports can be received via faxes, letters and e-mails. These reports are entered into
Medsafe's regulatory database by Medsafe staff. All reports are checked by us for correctness and
completeness. Valid reports received after 1 January 2013 may be published in the publicly
accessible database, Joint Adverse Event Notification System – Medical Devices.
How to report a problem
All reports are entered into a database assessed for risk and
kept for future reference.
- Serious adverse events are investigated immediately and given priority.
- Reports are assessed and a recommendation as to the appropriate type of investigation (if any) is made.
- Unusual incidents, incidents that led to injury or with unusually high levels of occurrence are
- Isolated incidents or incidents not likely to lead to injury or a detrimental effect to patients
or operators are not routinely investigated.
- Expert opinion may be sought during investigations.
The investigator will:
- contact the supplier of the device
- work with the supplier and the reporter of the incident to
- inform the reporter and supplier of the investigation
- keep reporter and patient identifying details confidential.
Final outcomes may include:
- informing health professionals and consumers through articles on Medsafe's website and other publications
such as Prescriber Update.
- requesting improvements to the product or changes to the instructions for use or
product labelling, such as adding warnings and precautions
- recalling the product from the market
- requesting the sponsor/manufacturer undertake additional user education
- requiring no further action at this stage, but continuing to monitor for trends.
Medsafe also exchanges information on significant incident investigations with overseas regulatory