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

Model Number 66021306

Device Problem Material Integrity Problem (2978)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, the allevyn life sacrum is "shedding" silicone onto the patient upon removal and it's difficult to remove from the skin.It's also shedding as the backing is removed before application.It is unknown how the procedure was finished or if there was any delay.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.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 raw material issues or storage environment issues.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 SACRUM (SMALL) PACK OF 10
• 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: 11057262
• MDR Text Key: 223192436
• Report Number: 8043484-2020-04350
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223481421
• UDI-Public: 05000223481421
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66021306
• Device Catalogue Number: 66801306
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1