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

Catalog 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	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a silicone layer problem occurred to the allevyn gentle border dressing.During set-up particles of silicone came loose of the silicone layer.Patient received a new box.No delay nor patient harm reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The device, used in treatment, has not been returned for evaluation, with no additional information provided.We have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Potential factors include raw material issues or storage environment issues.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.The complaint history review found further instances of the reported event in the past years.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 10X20CM
• Common Device Name: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11197558
• Report Number: 8043484-2021-00138
• Device Sequence Number: 13613618
• Product Code: NAD
• UDI-Device Identifier: 05000223463922
• UDI-Public: 05000223463922
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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 Catalogue Number: 66800900
• Device Lot Number: 201901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1