MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X30CM; DRESSING, WOUND, OCCLUSIVE

Model Number	66800265
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that silicone remains on the removable plastic part of the dressing.No patient was involved in this event.This issue was found on dressings from the sales representative's stock stored at normal temperature (below 25°c).
Additional Manufacturer Narrative
H3, h6: we have now concluded our investigation for the complaint received.A review of the associated batch manufacturing record did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition, it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was performed for the product and failure mode reported, there have been further instances in the past three years.The device, intended to be used in treatment, has been returned and evaluated establishing a relationship with the reported event.A visual inspection and functional evaluation confirmed the issue of silicone offsetting.The root cause was established as a raw material issue with the silicone adhesive on the wound contact layer.A corrective action is being carried out into this failure mode.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 10X30CM
• Common Device Name: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11100614
• Report Number: 8043484-2020-04415
• Device Sequence Number: 3282830
• Product Code: NAD
• UDI-Device Identifier: 05000223491864
• UDI-Public: 05000223491864
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66800265
• Device Catalogue Number: 66800265
• Device Lot Number: 201949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1