MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 12.5 X 12.5 CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number	66800272
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that three (3) allevyn gentle border 12.5 x 12.5 ctn 10 had the outer packing broken, and the surface of the product was contaminated.It is unknown whether this problem was noticed in a therapeutic environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
H3, h6: the product were returned for evaluation.The visual inspection of the returned product revealed that one of the pouches is open and there is contamination on the outside, this contamination is silicone adhesive.The review of the production records showed no manufacturing issues that could have contributed to the reported incident.No similar events were found in the complaint history, therefore this would suggest it is an isolated event.This event type is low occurrence/limited in scope, with no harms identified.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Additionally, there have been no previous investigations for the part number and failure mode reported.The root cause of the reported event was an issue during final inspection of the device.At this time, there is reason to suspect that the product failed to meet the product specifications at the time of manufacture, however, based on this investigation, the need for corrective action is not indicated.

• Brand Name: ALLEVYN GENTLE BORDER 12.5 X 12.5 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19961643
• Report Number: 8043484-2024-00078
• Device Sequence Number: 7080528
• Product Code: NAD
• UDI-Device Identifier: 05000223463960
• UDI-Public: 05000223463960
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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 Catalogue Number: 66800272
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown