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 Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  Injury  

Event Description

It was reported that allevyn gentle border dressings do not stay in place.Procedure was completed with a competitor device and no harm or injury reported.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the reported event and the device or determine a root cause on this occasion.Probable cause includes storage temperature, the ifu offers guidance on this matter, and or a product failure.A review of the manufacturing records found that there was no evidence that the product did not meet specifications at the time of manufacture.The complaint history review found other related events.The associated risk files contain details relating to harm.However, no harm has been alleged.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10798484
• MDR Text Key: 214989971
• Report Number: 8043484-2020-03754
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800272
• Device Lot Number: 202018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention