MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 10X20CM; DRESSING,WOUND,OCCLUSIVE

Model Number	66800900
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection upon removing the backing on this dressing a significant amount of the adhesive on the pad comes off onto the backing.No patient was involved.
Additional Manufacturer Narrative
We have now completed our investigation into the reported complaint.The device intended to be used in treatment has been returned and evaluated establishing a relationship with the reported event.The visual inspection found when the plastic handle was peeled off dressing, silicone offset onto the plastic handle.The functional evaluation confirmed that the dressing was less adhesive.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 10X20CM
• Common Device Name: 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: 11646758
• Report Number: 8043484-2021-00799
• Device Sequence Number: 19515539
• Product Code: NAD
• UDI-Device Identifier: 05000223476182
• UDI-Public: 05000223476182
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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
• Operator of Device: Health Professional
• Device Model Number: 66800900
• Device Catalogue Number: 66800900
• Device Lot Number: 202022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1