MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GB MULTISITE CTN 10; DRESSING,WOUND,OCCLUSIVE

Model Number	66800959
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	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during inspection the allevyn gb multisite ctn 10 silicone was offsetting to the back cover leaving the foam pad without silicone in various areas.It was a delay greater than 30 min.The patient was not injured and the procedure was completed with a smith-nephew back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: we have now concluded our investigation for the complaint received.The device, used in treatment, has not been returned for evaluation.Per reporter, the device is not available to be returned.However, a photo was provided which confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion.Potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history review found further instances of the reported event in the past years.These instances are currently being monitored, with actions being taken to reduce further instances.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: ALLEVYN GB MULTISITE CTN 10
• 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: 10991384
• Report Number: 8043484-2020-04174
• Device Sequence Number: 16341572
• Product Code: NAD
• UDI-Device Identifier: 05000223476502
• UDI-Public: 05000223476502
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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 Expiration Date: 05/01/2023
• Device Model Number: 66800959
• Device Catalogue Number: 66800959
• Device Lot Number: 202021
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1