Privacy notice for Medical Devices Incident Reporting

The HPRA operates the national system for recording and reporting details of suspected adverse reactions occurring in Ireland. The HPRA investigates all incidents reported to us in order to identify any faults with medical devices and to prevent similar incidents happening again. Your contact details included on this form will be primarily used for the purposes of interaction with you regarding this incident report. Your personal data (including your contact details) may be provided to the manufacturer, distributor or person responsible for the medical devices, known as the authorised representative. It may be necessary to share your personal data (including your contact details) with the healthcare professional associated with this medical device and/or your related health needs. Please see full details of how personal data is processed in this area.

Medical Device Incident User Report Form

Fields marked with an asterisk (*) are mandatory.

To move through the steps of the form please use the Next and Previous buttons that are at the bottom of the form.

  • Reporter Information
  • Device & Incident Details
  • Photos & Files
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Reporter Information