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Patterson Walking Frames (wheeled and non-wheeled)

Notice type: Advisory

Date: 17/12/2013

  

Product name or type:
Patterson Walking Frames (wheeled and non-wheeled)

Reference:
SN2013(16)

Manufacturer Or Supplier:
Patterson Medical Limited

Target Audience:
General Public 
Hospital CEOs 
Risk Managers 
Procurement Managers 
Loan Store Managers 
HSE Offices 
Community Care Centres 
Occupational Therapists 
Community Care Managers 
Community Therapists 
Physiotherapists 
Health Visitors 
Carers

Problem Or Issue:
Patterson Medical has become aware that due to a manufacturing issue a number of walking frames are potentially affected by wheel detachment and/or inadequately tightened screws.

Background Information Or Related Documents:
Patterson have received reports that on specific batches of Patterson walking frames the wheels may become detached and/or have inadequately tightened screws, which may cause the user to fall. This problem affects batch codes DMW12013 to DMW82013 inclusively, across all models of Patterson walking frames (wheeled and non-wheeled), supplied between January and March 2013. Patterson Medical has asked that all walking frames from the affected batches be checked according to the details supplied in the field safety notice. 

Patterson Medical and their Irish distributors have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. There are approximately 561 Patterson Walking Frames on the Irish market, which require device checks.

Patterson Walking Frames (wheeled and non-wheeled) Document

Actions To Be Taken:
The IMB advises that users: 

1. Identify all affected batches of the walking frames. 

2. Perform the checks and actions detailed in the manufactures field safety notice. 

3. Complete and return the reply letter to Patterson Medical Ltd, if not already completed.

Further Information:
Enquiries should be addressed to the Irish supplier / distributor of the device or to Patterson Medical at: 

Emma Davies 
Patterson Medical Limited 
Nunn Brook Road 
Huthwaite 
Sutton in Ashfield 
Nottinghamshire 
NG17 2HU, UK 

Telephone: 00-44-1623448706 
Fax: 00-44-1623448784 
Email: emma.davies@pattersonmedical.com 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie

Please click here to view a PDF version of the Safety Notice

Please click here to view a PDF version of the Field Safety Notice

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