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

Model Number 66800279

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 211425720
• Report Number: 8043484-2020-03209
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223463960
• UDI-Public: 05000223463960
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 66800279
• Device Catalogue Number: 66800275
• Device Lot Number: 202020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1