The following page provides Guidance on reporting adverse incidents to NIAIC

How to Report an Adverse Incident 

Guidance for reporting adverse incidents to NIAIC is contained in NIAIC Publication - Reporting Adverse Incidents - distributed in Northern Ireland only.

To report an incident click on the link below for the report form available as a Word or pdf file and return this directly by e-mail or post to the NIAIC,  at the address on the form.

If you are in doubt about how to report incidents, please contact the NIAIC or if you work for a HSC body contact your Medical Device liaison officer. Incidents relating to medical devices, non-medical equipment, plant and building items must reported to NIAIC as soon as possible.

Please provide as much information as possible in completion of any Incident report form. Information about the medical device or item of equipment involved should include details of the manufacturer and supplier  including  address and telephone number, the individual product name and the serial number if available. Names and contact details of persons who may be contacted for further information are also required to assist in any investigation.

What is an Adverse Incident 

An adverse incident is an event which causes, or has the potential to cause, unexpected or unwanted effects that will involve the safety of patients, staff, users and other people.

Adverse incidents can occur from malfunction of  the device, unclear or incorrect user instructions, user practices, equipment servicing and maintenance or the conditions of use. The importance of an incident is not always obvious, and types of incidents can vary from the extremely serious (death or serious injury) to the apparently minor.

All Adverse incidents involving medical devices or estates related equipment should be reported.  Please include near misses and minor safety issues as the recording of these incidents enables comparison with new reportes and can aid identification of underlying issues.  For information on how your report will be handled, please refer to our privacy notice. 

 

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