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

Catalog Number UNKNOWN

Device Problem Material Integrity Problem (2978)

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 a patch, (5-10 pence size), of silicone missing from an allevyn gentle border dressing upon removal.Nor a batch number or samples are available for evaluation.It was used on a pu on a heel.Upon further discussion it was revealed that the dressing had a trauma underneath and it was a dry necrotic wound.It could not be confirmed if the transfer of silicone had occurred and there was no silicone reported in the wound bed so it was not possible to establish whether this silicone off set occurred prior to dressing application i.E did it go on the backing paper or upon dressing removal.It was also recalled that when the dressing was applied on (b)(6) 2020 it was lifted and repositioned a few times.

Manufacturer Narrative

The device, used in treatment, has not been 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 include product failure or storage temperature, the instruction for use offer further guidance.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.This investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• 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: 10503311
• MDR Text Key: 205956759
• Report Number: 8043484-2020-02764
• 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: 02/01/2021

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: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1