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

Model Number 66801069

Device Problems Loss of or Failure to Bond (1068); Defective Device (2588)

Patient Problem Skin Infection (4544)

Event Date 02/12/2021

Event Type  Injury  

Event Description

It was reported that, during treatment, customer stated that allevyn device form of absorption does not occur in a vertical way, but in a transversal way, macerating the margins.There is also the displacement of the covering on the skin causing the edges to curl, implying frequent changes of the covering.Also, complained that the packaging / seal for being transparent is difficult to release the foam, compromising the application of the product and the aseptic technique.The treatment was completed without delay using a smith & nephew back-up device.No other complications were reported.

Manufacturer Narrative

We have now completed our investigation into the reported complaint.The device used in treatment has not been returned for evaluation.The photo provided confirms a relationship between the device and the reported event.Potential factors that can contribute to the reported event include the wound contact layer raw material quality issue.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.Risk management files contain the reported failure mode.No update required.A clinical/medical assessment was performed and determined no further actions are required.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.The complaint history file contains further instances of the reported event, currently being monitored, with actions being taken to reduce further instances.However, this investigation is now complete with no further action deemed necessary at this stage, 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.

• Brand Name: ALLEVYN LIFE L 15.4X15.4 CTN10
• Type of Device: 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: 11478989
• MDR Text Key: 239683983
• Report Number: 8043484-2021-00563
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223478049
• UDI-Public: 05000223478049
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66801069
• Device Catalogue Number: 66801069
• Device Lot Number: 202022
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention