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

Model Number	66800280
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8043484-2021-00578
• Device Sequence Number: 14194413
• Product Code: NAD
• UDI-Device Identifier: 05000223463991
• UDI-Public: 05000223463991
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66800280
• Device Catalogue Number: 66800273
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1