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	05/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment, the allevyn gb multisite silicone strongly remained on the pack when removing it for application.Also, once the dressing was being removed from the patient after it use, the silicone remained on the healthy skin or on the patient's wound.This has happened in multiple occasions, and the use of the dressing is being replaced for a competitor's dressing: mepilex from molnlycke.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, is not available 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.
Additional Manufacturer Narrative
The device, intended to be used in treatment, was returned for evaluation, establishing a relationship between the device and the reported event.A visual inspection found silicone offset onto the plastic handle when the plastic handles were peeled off dressing.The functional evaluation confirmed that the dressings were less adhesive.Root cause has been determined as a component failure, the wound contact layer within these dressings can be affected by storage temperature fluctuations as detailed in the ifu.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.Since no patient injuries were reported, no further clinical/medical assessment is warranted.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.A complaint history review has found other related events, with corrective action implemented related to the reported event.Smith + nephew will continue to monitor for adverse trends.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11852471
• Report Number: 8043484-2021-01181
• Device Sequence Number: 19620165
• Product Code: NAD
• UDI-Device Identifier: 05000223476502
• UDI-Public: 05000223476502
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 07/01/2021
• Device Model Number: 66800959
• Device Catalogue Number: 66800959
• Device Lot Number: 201831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 11/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/02/2021; 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown