MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN AG GB 12.5X12.5CM -GLOBAL CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800438

Device Problem Suction Problem (2170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

It was reported that the dressing is not absorbent enough compared to similar dressings from other brands.

Manufacturer Narrative

We have now concluded our investigation into this complaint.A review of the associated batch manufacturing records 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.The complaint sample was returned for evaluation and no issue was found.No functional or visual issues were identified and all aspects of the sample were as expected.A review of our database has found this complaint to be the only complaint received for this issue for this product code and lot number therefore deemed an isolated incident.The investigation did not find product defect or manufacturing process issue so no action is required at present 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 AG GB 12.5X12.5CM -GLOBAL CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8224447
• MDR Text Key: 132344210
• Report Number: 8043484-2019-00020
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800438
• Device Lot Number: 201702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1