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

Catalog Number	66800959
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the known issue with silicone occurred.Old production was delivered to customer against earlier agreed intervention.No patient was involved.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.Visual inspection confirmed silicone remained on the carrier.The functional evaluation confirmed reduced adherence, establishing a relationship with the reported event.The root cause has been identified as a raw material issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event in the past years, 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: 10508702
• Report Number: 8043484-2020-02786
• Device Sequence Number: 13770627
• Product Code: NAD
• UDI-Device Identifier: 05000223476519
• UDI-Public: 5000223476519
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 66800959
• Device Lot Number: 201850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1