MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN ALLEVYN GENTLE BORDER; DRESSING, WOUND, OCCLUSIVE

Catalog Number UNKNOWN

Device Problem Loss of or Failure to Bond (1068)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

It was reported that the tissue viability nurse noticed some silicone off setting on the edge of the backing paper of the allevyn gentle border that she used on (b)(6) 2020.No patient harm reported.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation.No additional information was provided, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes could include a raw material failure.A review of the associated batch manufacturing records could not be carried out as no batch/lot number has been provided, however, at this time, we have no reason to suspect that the product did not meet specifications at the time of manufacture.The complaint history review found further instances of the reported event in the past years.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN ALLEVYN GENTLE BORDER
• 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: 10504746
• MDR Text Key: 206085110
• Report Number: 8043484-2020-02768
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1