MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER LITE 5.5X12CM; DRESSING,WOUND,OCCLUSIVE

Model Number	66800836
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	05/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, in several treatments, the silicone of the allevyn gentle border lite 5.5x12cm remains strongly on the blister pack, but also during removal, the silicone remains on the healthy skin or on the patient's wound, due to this the use of the dressing is being replaced for a competitor's dressing (mepilex from molnlycke).According to sales representatives, this was not a problem on one batch, but a generalized problem.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, has not been returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Factors that can contribute to the reported event include raw material quality issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain the reported failure or event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GENTLE BORDER LITE 5.5X12CM
• 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: 11852363
• Report Number: 8043484-2021-01179
• Device Sequence Number: 16931111
• Product Code: NAD
• UDI-Device Identifier: 05000223475529
• UDI-Public: 05000223475529
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: 66800836
• Device Catalogue Number: 66800836
• Device Lot Number: 202002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention