MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE M 12.9X12.9 CTN10; DRESSING, WOUND, OCCLUSIVE

Model Number	66801068
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint: (b)(4).
Event or Problem Description
It was reported that some allevyn life dressings have peeling problems.The silicone is coming off either onto the patient's skin or onto the plastic protector of the dressing.Silicone residue was left in the periwound skin of the patient.The wound was cleansed and the silicone removed.Another dressing was applied to continue treatment with no delay.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.The device used in treatment has not been returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Potential factors include the wound contact layer raw material quality issue.The clinical evaluation concluded: without relevant clinical information, photos or the product the reported failure cannot be confirmed.The associated risk files contain the reported failure, with no additional actions necessary.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture, complaint history file contains further instances.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: ALLEVYN LIFE M 12.9X12.9 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
• MDR Report Key: 10915090
• Report Number: 8043484-2020-04005
• Device Sequence Number: 19121162
• Product Code: NAD
• UDI-Device Identifier: 05000223478018
• UDI-Public: 05000223478018
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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 Model Number: 66801068
• Device Catalogue Number: 66801068
• Device Lot Number: 202019
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 11/27/2020
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention