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

Catalog Number 66800270

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up the silicone in the allevyn gentle border is offsetting to the back cover leaving the foam pad without silicone in various areas.Delay in treatment greater to 30 minutes.Smith and nephew backup device available.No injury to patient reported due this event.

Manufacturer Narrative

H3, h6: we have now concluded our investigation for the complaint received.The device, used in treatment, has not been returned for evaluation.Per reporter, the device is not available to be returned.However, a photo was provided which confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion.Potential factors that can contribute to the reported event include the wound contact layer raw material quality 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 in the past years.These instances are currently being monitored, with actions being taken to reduce further instances.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER 10 X 10CM CTN 10
• 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: 10971745
• MDR Text Key: 220411178
• Report Number: 8043484-2020-04127
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800270
• Device Lot Number: 202021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1