MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 12.5 X 12.5 CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800272

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Event Description

It was reported that during treatment the adhesive was found to fall off badly and sticks to the wound bed and surrounding skin patient, there was no harm and medical intervention to remove the residue was not necessary.

Manufacturer Narrative

We have now concluded our investigation into this complaint.The batch record was reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issues identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this issue in the past four years.The product was used for treatment.It was reported that the silicone of the wound contact layer of the dressing was found to stick to the wound site and surrounding skin.It was also found that the edge curled easy.The returned sample was evaluated which confirmed the presence of silicone offsetting, however, the wound contact surface of allevyn gentle border is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.No other issues were found with the returned samples.As a large internal investigation is being carried out into silicone offsetting, no further action is deemed necessary.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER 12.5 X 12.5 CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9540259
• MDR Text Key: 174194832
• Report Number: 8043484-2020-00001
• Device Sequence Number: 1
• Product Code: NAD
• 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,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800272
• Device Lot Number: 1902
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1