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

Model Number	66800900
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that many pieces of the adhesive edge of the allevyn gentle border dressings come loose in several sizes.It sticks to the sink and the floor.This happened specially to the bottom and sides of the patches.It is unknown if a patient was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.All supplied information has been reviewed and we were unable to establish a relationship between the device and the reported event or to determine a root cause.Probable root causes may include storage temperature or component failure.No lot/batch number has been provided, therefore a review of the manufacturing records is not possible.A complaint history review found further instances of the reported event.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 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: 11490632
• Report Number: 8043484-2021-00576
• Device Sequence Number: 19574543
• Product Code: NAD
• UDI-Device Identifier: 05000223476182
• UDI-Public: 05000223476182
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: UNKNOWN
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1