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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after an unknown number of allevyn life 15.4 cm x 15.4cm ctn 10s were removed from the skin, a residue of silicone adhesive was left on the skin of the patients.Patients were not harmed.Further information is not available.
Additional Manufacturer Narrative
We have now concluded our investigation into the reported complaint.As no lot number information was provided a review of the device history record could not be carried out.A complaint history review, was performed for the product and event description, there have been similar instances reported in the past three years.Event occurred during patient treatment.The device used in treatment was not returned for evaluation, therefore no functional evaluation could not be carried out.We have not been able to establish a relationship between the reported complaint and the device.It has not been possible to establish the root cause of the issue.Probable root causes include environmental factors such as temperature, which can affect the adhesive nature of the dressing and also procedural issues, such as incorrect skin preparation, application or removal of dressings.The users of the reported product are advised to consult the ifu, to delineate future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including application and removal of dressings the investigation has been closed no further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• 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
• MDR Report Key: 11816123
• Report Number: 8043484-2021-01105
• Device Sequence Number: 19639405
• Product Code: NAD
• UDI-Device Identifier: 05000223478049
• UDI-Public: 05000223478049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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 Model Number: 66801069
• Device Catalogue Number: 66801069
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1