MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X25CM; DRESSING,WOUND,OCCLUSIVE

Model Number 66800264

Device Problems Loss of or Failure to Bond (1068); Nonstandard Device (1420)

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

Event Date 03/17/2021

Event Type  malfunction  

Event Description

It was reported that, while checking the allevyn devices and upon removing the backing on this dressing almost all of the adhesive on the pad comes off on the backing.No case involved; therefore, no patient involvement.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.The device intended to be used in treatment has not been returned, however the supplied photos have been reviewed, establishing a relationship with the reported event.It was reported that the adhesive on the pad comes off on the backing.A wound contact layer raw material quality issue has been identified as the root cause.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events.An ongoing internal action is being carried out into the reported failure mode to reduce further instances of the reported event, therefore no further actions are deemed necessary into this specific complaint.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 10X25CM
• 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: 11646751
• MDR Text Key: 244848610
• Report Number: 8043484-2021-00791
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223491833
• UDI-Public: 05000223491833
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800264
• Device Catalogue Number: 66800264
• Device Lot Number: 202031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1