MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE L 15.4X15.4 CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number	66801069
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an arthroscopy (acl or other), upon removal of the allevyn life l 15.4x15.4 ctn10, it was observed that the patient's skin was macerated.Also, according to client´s description there was a lot of adhesive residue.Treatment was resumed, with a greater 30 minutes delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned 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.A probable root cause may include a component failure, the wound contact layer within these dressing 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 instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.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 LIFE L 15.4X15.4 CTN10
• 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: 12894272
• Report Number: 8043484-2021-01983
• Device Sequence Number: 3459266
• Product Code: NAD
• UDI-Device Identifier: 05000223478049
• UDI-Public: 05000223478049
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2022

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: 03/01/2024
• Device Model Number: 66801069
• Device Catalogue Number: 66801069
• Device Lot Number: 202110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown