MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE L 15.4X15.4 CTN10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66801069

Device Problem Inadequate Filtration Process (2308)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 06/18/2018

Event Type  Injury  

Event Description

It was reported that in a follow-up of dressing changes, the non-absorption of the exudate was observed, causing damage to the adjacent skin such as maceration, hyperemia and dermatitis.It was noticed that the exudate slipped down to the sides, releasing the adhesive from the edge.With the impression of an impermeability of silicone which did not allow the correct absorption proposed for the dressing.

Manufacturer Narrative

The batch records of code 66801069, batch 201644 have been reviewed and there was no issue identified during manufacturing process that could have caused or contributed to the complaint problem.No sample was received for assessment.The investigation does not find any fault in the process and therefore no action is required in suzhou plant because it is a non-manufacturing related complaint.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 L 15.4X15.4 CTN10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull, HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD; 101 hessle road; hull, HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull, HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7683845
• MDR Text Key: 113863504
• Report Number: 8043484-2018-00176
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66801069
• Device Lot Number: 201644
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention