Report an adverse event for medical devices

An adverse event is any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good. An abnormal laboratory finding could be one example of an unfavourable and intended sign.

In the case of medical devices, an adverse event can also be a problem or incident that has caused, or could cause, harm to patients, caregivers, health professionals or others. These can include 'near misses' – events that might have led to a death or serious injury. It may be that timely intervention from a health professional prevented an adverse event.

Importantly, an adverse event is not always caused by the therapeutic good itself. An adverse event could be a result of incorrect user interaction or other circumstances such as two properly functioning devices that do not operate as intended when used in combination. The occurrence of an adverse event does not necessarily mean that there is something wrong with the therapeutic good.

Reporting an adverse event for a medical device

To report an adverse event for a medical device, you will need to use the Medical Device Incident Reporting (MDIR) system. The information in the MDIR system is secure with users needing to log in to the MDIR system using their TGA eBS user name and password.

All sponsors and manufacturers should complete the online forms available in the Medical Device Incident Reporting (MDIR) system for submitting initial, follow-up and final reports.

Medical Device Incident Reporting (MDIR) system

If you require assistance to report a medical device problem, call 1800 809 361 (08:30 am to 5:00 pm, Monday to Friday) or email IRIS@health.gov.au