MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE M 12.9X12.9 CTN10; DRESSING, WOUND, OCCLUSIVE

Model Number 66801068

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Event Description

It was reported that for several allevyn life m 12.9 x 12.9 ctn10, the dressing's silicone is coming off in large sections onto the backing and onto the patients.Because of this, they are unable to follow the prevention protocol because the dressing barely lasts one shift.Silicone is everywhere, and not adhering when lifted for assessment.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing record did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The devices were intended for use in treatment, according to the description of complaint, the complaint issue is silicone offsetting.This confirmed a relationship between the event and the device.The wound contact surface of the allevyn life is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is possible the silicone adhesive on the wound contact layer has problem, the potential cause of this failure mode could have been due to the raw materials issue.An ongoing internal project is being carried out into this failure mode, therefore no further actions are deemed necessary into these specific complaints.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN LIFE M 12.9X12.9 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: 10680401
• MDR Text Key: 211367774
• Report Number: 8043484-2020-03202
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223478018
• UDI-Public: 05000223478018
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66801068
• Device Catalogue Number: 66801068
• Device Lot Number: 202017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1