Reporting adverse incidents involving medical devices

Full information and guidance on reporting Adverse Incidents is published in MHRA Device Bulletin DB2008(01) Reporting Adverse Incidents and Disseminating Medical Device Alerts.

As part of the re-development of this website, the medical device online adverse incident report forms have been re-styled. The functionality of the online systems remain unchanged, but the look and feel of the web pages has been transformed into a style and format in keeping with the main website.

MORE Manufacturer Online Reporting Environment Use this link to Register and to Login to MORE, the online reporting system for medical device manufacturers and suppliers, and their authorised representatives. Enquiries about MORE should be directed to: aic@mhra.gsi.gov.uk 020 7084 3080

User Reporting User Reporting online Use this link to access the online adverse incident reporting forms for medical device users, healthcare professionals, carers, and members of the public. Paper report forms may be downloaded from the table below.

Reporting online
The MHRA prefers to receive adverse incident reports online. Using MORE or the User reporting system to submit a completed report form will prompt an automatic acknowledgement and the immediate electronic allocation of a unique MHRA adverse incident reference number.

The reference number will appear in the following format: 2005/002/014/401/047

If you do NOT automatically receive an MHRA reference number, please contact the Adverse Incident Centre by other means (i.e. e-mail, telephone or fax).

Alternative reporting methods

E-mail - Download one of our standard report forms (see below) as an MS Word or rtf document, fill in the relevant sections as completely as you are able, and then e-mail it, preferably as an MS Word 97 attachment, to aic@mhra.gsi.gov.uk

Fax/Mail - Forms may also be downloaded as pdf documents. These can be completed and faxed to the Adverse Incident Centre on 020 7084 3109, or mailed to the Adverse Incident Centre:

Telephone - Telephone reports are only for incidents involving death, serious injury or serious public health concern. These must always be followed by a confirmatory written report. You can contact the AIC Hotline on 020 7084 3080.

Enquiries
The AIC Hotline, 020 7084 3080, will also help with practical questions on reporting adverse incidents and can also provide updates on the progress of ongoing incident investigations.

Out of Hours
Outside of normal office hours, the AIC Hotline will connect to an answering machine. This machine carries a message that includes the telephone number of the Department of Health switchboard. In cases of urgency they are able to contact senior MHRA officials.

Adverse Incident Report Forms
Please click on the relevant form to download the appropriate Word, rtf or pdf document:

Device(s)/Type	Document filename	Choose format
General Medical Devices	general	MS Word (59Kb)	RTF (74Kb)	PDF (29Kb)
Wheeled Mobility & associated equipment	Wheelchair	MS Word (59Kb)	RTF (98Kb)	PDF (25Kb)
In vitro Diagnostic Devices	IVD	MS Word (49Kb)	RTF (61Kb)	PDF (31Kb)
Hip & Knee implants	Hip&Knee	MS Word (67Kb)	RTF (105Kb)	PDF (34Kb)
Implantable pacemakers/defibrillators	Pacemaker	MS Word (629Kb)	RTF (280Kb)	PDF (50Kb)
Limb prosthesis	Limb_prosthesis	MS Word (67Kb)	RTF (103Kb)	PDF (25Kb)
Orthotic Devices	Orthotic	MS Word (44Kb)	RTF (47Kb)	PDF (16Kb)
Breast Implants - Public	Breast implant - Public	MS Word (68Kb)	RTF (73Kb)	PDF (25Kb)
Breast Implants - Surgeon	Breast implant - Surgeon	MS Word (78Kb)	RTF (92Kb)	PDF (104Kb)
Cochlear implants	Cochlear implant	MS Word (89Kb)	RTF (152Kb)	PDF (74Kb)
Member of public report on any medical device	Public	MS Word (40Kb)	RTF (42Kb)	PDF (25Kb)

Report forms for manufacturer reporting
We recommend that manufacturers or their authorised representatives use MORE our Manufacturer Online Reporting Environment, for reporting incidents and field safety corrective actions to MHRA. We also recommend that manufacturers use the suggested Field Safety Notices form below for communicating this information to MHRA and UK users. If using MORE the FSN can be included as a file attachment.

Type	Document filename	Choose format
Incident	Incidentv1	MS Word (165Kb)	RTF (349Kb)	PDF (26Kb)
Field Safety Corrective Action	FSCAv1	MS Word (121Kb)	RTF (241Kb)	PDF (21Kb)
Field Safety Notice	FSNv1	MS Word (35Kb)	RTF (24Kb)	PDF (19Kb)

General information and Published Guidance
All adverse incidents involving medical devices must be reported to MHRA as soon as possible, even if user error (rather than a device problem) is suspected.

Whilst the MHRA would like your initial report of an incident to contain as much relevant detail as is available, submission should not be unnecessarily delayed. However, it is important that names and contact details of persons who may be contacted for further information should be included on the form.

Serious cases must be reported to MHRA by the fastest means available.

Telephone reports, taken only for incidents involving death, serious injury or serious public health concern, should be followed up as soon as possible by a written report.

For the latest guidance of what to do with devices that have been involved in incidents please refer to Device Bulletin DB2008(01). If it is your intention to send the device concerned to the MHRA please ensure it is decontaminated. It is illegal to send contaminated items through the post.

This site also contains more comprehensive information about incident reporting procedure and the Adverse Incident Centre.

*The devolved administrations' equivalents to MDA/2007/001 are :

If you are in doubt about the reporting procedure please seek advice from your line manager or contact the MHRA Medical Device Adverse Incident Centre.