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

Catalog Number 66801307

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  malfunction  

Event Description

It was reported that customer first let representative knows of the issue when s & n was aware that there was a silicone issue with the allevyn dressings.After finding the issue and changed the manufacturing process, representative let the customer know she shouldn't be seeing this problem any longer.As of today, 5/26/2020, my customer said she has been meaning to send me pictures of the silicone issue still occurring.Photos attached and no harm or injury to the patient reported.

Manufacturer Narrative

The device used in treatment has not been returned for evaluation, but photos with additional information provided we have been able to establish a relationship between the device and the reported event.The photos supplied confirm silicone gel offset to patients¿ skin.The probable root cause is a raw material issue.The manufacturing records cannot be reviewed as no lot or batch number was provided.The complaint history file contains further instances of the reported events; however, this investigation is now complete with no further action deemed necessary at this stage.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: ALLEVYN LIFE SACRUM (LARGE) PACK OF 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10169588
• MDR Text Key: 195614483
• Report Number: 8043484-2020-00834
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 04582111154972
• UDI-Public: 4582111154972
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801307
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1