MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN THIN 15X15CM CTN 3; DRESSING, WOUND, OCCLUSIVE

Catalog Number 66045124

Device Problem Difficult to Remove (1528)

Patient Problem Peeling (1999)

Event Date 05/07/2021

Event Type  Injury  

Event Description

It was reported that, during treatment, an allevyn thin 15x15cm ctn 3 peeled off the skin when it was removed from the patient, causing a major superficial skin defect.Treatment was resumed with a competitor device.The patient was not injured beyond the described event.No other complications were reported.

Manufacturer Narrative

Additional information: a2, b4.

Event Description

It was reported that, during treatment, an allevyn thin 15x15cm ctn 3 peeled off the skin when it was removed from the patient, causing a major superficial skin defect.Treatment was resumed with a competitor device with significant delay.The patient was not injured beyond the described event.No other complications were reported.

Manufacturer Narrative

We have now concluded our investigation into the reported complaint.As no lot number was provided, it was not possible to carry out a device history review.A complaint history review was performed for the product and event description and there have been no similar instances reported in the past three years.Event occurred during patient treatment.The device used in treatment was not returned for evaluation, therefore functional evaluation could not be carried out.We have not been able to establish a relationship between the reported event and the device.The instructions for use for the product provides comprehensive instructions of the operation, use and limitations of the device, including the application and removal of the dressings.It cannot be concluded that the technique in which the dressing was applied and/or removed contributed to the adherence of the patient¿s skin to the allevyn thin dressing.Therefore, the root cause of the reported event cannot be definitively determined.However, a probable root cause is a procedural related event.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.

• Brand Name: ALLEVYN THIN 15X15CM CTN 3
• 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: 11882830
• MDR Text Key: 252692267
• Report Number: 8043484-2021-01215
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66045124
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 05/19/2021; 10/15/2021
• Supplement Dates FDA Received: 06/02/2021; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR