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What is an adverse incident?

The MHRA define an adverse incident as "an event that causes, or has the potential to cause, unexpected or unwanted effects
involving the safety of device users (including patients) or other persons." In other words any actual or potential adverse event
which occurs when employing a device which affects the patient, healthcare professional or other user

What to report
Any adverse incident involving a device should be reported to the MHRA, including problems with the instructions for use or
difficulties with deployment, especially if the incident has led, or might have led to:

• deterioration in health or permanent impairment of body structure or function
• the necessity for medical or surgical intervention (including implant revision)
• hospitalisation or prolongation of existing hospitalisation
• death, life-threatening illness or injury

For synthetic meshes for prolapse and incontinence this may include:
• Vaginal exposure
• Erosion into the urinary tract
• Erosion into the bowel or rectum
• Infection
• Pain
• Fistulae
• Mesh shrinkage
• Organ perforation
• Nerve or vascular injury
• Sexual difficulty

These may present to the original operating surgeon but may present later to other gynaecologists, urologists or colorectal

Who should report
Adverse incidents can be reported by
1. Clinicians and healthcare workers
2. Patients and members of the public
3. Device manufacturers

Confidentiality and data protection
The MHRA does not require patient names or other identifying information in order to carry out an investigation. Healthcare staff
reporting incidents should, therefore, ensure that such details are deleted or redacted from their reports, from accompanying
attachments and from any subsequent correspondence.

The details required by the MHRA are specified on the report forms. The reporter's full contact details (name, post held etc.)
are essential, as this allows the MHRA to contact the reporter to acknowledge receipt of the report and request any further
information that may be needed.

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