MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (SMALL) PACK OF 10; DRESSING,WOUND,OCCLUSIVE

Model Number	66021306
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during and after procedure, it was detected that silicone gets attached to the dressing liner while removing the liner for application.Silicone will stay on the wound while removing the dressing for change.The procedure was completed with a delay in wound healing of more than 30 minutes.The procedure was completed using a smith & nephew back-up device.No other complications were reported.
Additional Manufacturer Narrative
G4, h2, h6: the device used in treatment has not been returned for evaluation.The video provided confirms a relationship between the device and the reported event.Silicone remained on the carrier paper reducing adhesion.Potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances of the reported events, currently being monitored, with actions being taken to reduce further instances.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products e1: facility and address update.

• Brand Name: ALLEVYN LIFE SACRUM (SMALL) PACK OF 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: 11429738
• Report Number: 8043484-2021-00465
• Device Sequence Number: 3619141
• Product Code: NAD
• UDI-Device Identifier: 05000223481421
• UDI-Public: 05000223481421
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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 Expiration Date: 03/01/2023
• Device Model Number: 66021306
• Device Catalogue Number: 66801306
• Device Lot Number: 202010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/07/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1