MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 12.5CM X 12.5CM; DRESSING, WOUND, OCCLUSIVE

Model Number	66800279
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sales rep found when opening dressings from her new demonstration stock that silicone remains attached to the removable plastic part.There is no silicone at all on the dressing side.No patient involved.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The device used in treatment has not been returned for evaluation.The photo provided confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion, with the root cause identified as a raw material issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.This investigation is now complete with no further action deemed necessary at this stage.Smith + 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 12.5CM X 12.5CM
• 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: 10680867
• Report Number: 8043484-2020-03209
• Device Sequence Number: 16879531
• Product Code: NAD
• UDI-Device Identifier: 05000223463960
• UDI-Public: 05000223463960
• 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): 02/01/2021

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: 66800279
• Device Catalogue Number: 66800275
• Device Lot Number: 202020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1