Reporting a Medical Device Adverse Incident

When should I report an incident?
If a medical device poses a risk to your health and safety, stop using it where possible and report the problem to your healthcare provider, the IMB or the manufacturer of the device. You should report any unexpected problem or malfunction that may affect your health, cause or contribute to an injury and/or lead to incorrect treatment.

How do I report an incident?
You can report incidents to the IMB by filling in the online adverse incident user report form. A downloadable version of the form is also available, which can be filled in manually and sent to the IMB by post or by emailing medicaldevices@imb.ie.

Further Information
The IMB has published a series of information leaflets that highlight key safety issues relating to both the purchase and use of medical devices.

The Irish Medicines Board - www.imb.ie

Reporting a Medical Device Adverse Incident