MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 17.5X17.5CM CTN 10; DRESSING,WOUND,OCCLUSIVE

Model Number 66800280

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that many pieces of the adhesive edge of the allevyn gentle border dressings come loose in several sizes.It sticks to the sink and the floor.This happened specially to the bottom and sides of the patches.It is unknown if a patient was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The dressing was coming loose which will usually require a new dressing to be applied, there was no patient injury or intervention required.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

Event Description

It was reported that, while the patient was undergoing wound treatment, the adhesive edge from three types of allevyn gentle border foams (10x20 cm, 10x20 cm lite, 17.5x17.5cm) kept coming loose.The patient was getting very irritated as fragments sticked to the sink and to the floor, so the whole mess needed to be washed off every time.The problem was worse in the largest sizes, especially around the adhesive edge, with a small difference at the top of the layer where it also happened, but was slightly less than the bottom and the sides.It is unknown the amount of dressings with this problem the patient noticed.It is also unknown if any dressing with this condition was used in the wound and, if so, how the problem was addressed.Patient was not harmed.

• Brand Name: ALLEVYN GENTLE BORDER 17.5X17.5CM CTN 10
• 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: 11490638
• MDR Text Key: 240030030
• Report Number: 8043484-2021-00578
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223463991
• UDI-Public: 05000223463991
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800280
• Device Catalogue Number: 66800273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1