Reporting device safety issues for patients and members of the public

What should I do if I notice a safety issue with a device?

You should report any problem with your device to your healthcare provider immediately for advice on what to do.

You should also report the issue to us and to the device manufacturer.

How can I report a safety issue with a device to the HPRA?

There are different ways to report a safety issue to us.

• You can use our online report form.
• You can email us at devicesafety@hpra.ie.
• You can download a copy of our report form linked below and email it to devicesafety@hpra.ie or post it to Medical Devices Department, HPRA, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77.
• You can phone us at +353 (0)1 676 4971.

You can submit a report for someone in your care.

What happens when I report to the HPRA?

When you submit a report to us, we;

• Review your report,
• Let you know we received it.
• Contact the manufacturer to inform them of the report.
• May contact you for more details about your experience.

Reports can help us to find new safety issues and trends.

Every report counts and helps to make devices as safe as possible.

More details on our data protection policy please click the link below.