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

Catalog Number 66801068

Device Problem Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); Skin Tears (2516)

Event Date 12/10/2018

Event Type  Injury  

Event Description

Skin tear upon removal of silicone adhesive dressing.Cancer patient with existing skin tear.Customer claims allevyn life placed over skin tear and upon removal a new tear occurred near the original tear.

Event Description

It was reported that a patient suffered a skin tear upon removal of silicone adhesive dressing.Cancer patient with existing skin tear.Customer claims allevyn life placed over skin tear and upon removal a new tear occurred near the original tear.

Manufacturer Narrative

We have now concluded our investigation into this complaint.No dhr/batch record review was possible as no lot numbers have been made available and no sample was available for assessment.The database of change controls was reviewed and found there was no raw material, methods of manufacture or manufacturing equipment changed since the original qualification exercises that could have caused or contributed to the issue experienced by the customer or alleged adverse reactions.A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The supplier report deemed the complaint as non manufacturing.The ifu does include precautionary statements regarding use on fragile skin and removal.In conclusion: based on the limited information provided, currently unable to rule out the already compromised skin integrity from the variety of reported insults as the main contributing factor to the reported excoriation and/or maceration along with the common complication of skinfolds harboring moisture and the possibility of shear and/or friction forces at this vulnerable (gluteal) location.The patient impact was the reported excoriation and/or maceration, possible pain/discomfort as well as an additional entry site/risk for infection.No further medical assessment can be rendered at this time.Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present.Once a sample is received, we will assess and make further investigation.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 ; UK
• MDR Report Key: 8215336
• MDR Text Key: 132065065
• Report Number: 8043484-2019-00010
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801068
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other