MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 28X30CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Catalog Number	4987
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up for a treatment it was noticed that the outer packaging of one (1) opsite incise 28x30cm ctn 10 was not sealed on one side.Sterility of the product is therefore no longer guaranteed and can lead to infections in the operating room.It is unknown how the procedure was completed.The procedure was resumed, after a non-significant delay.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the product was returned for evaluation.A visual inspection of the returned dressing pouch found one side of the pouch was opened.Lacquer transfer was visible at the open side.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.A historical review concluded that there have been no previous escalated actions for the part number and failure mode reported.The sealed pouches are all inspected to ensure the products that do not meet specifications are rejected.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The sealing process was reviewed.On the sealing machine the printed paper is heated and the lacquer on printed paper transfers to plain paper to form 4-side seal of pouch.Then the sealed pouches are all inspected to ensure the products that do not meet specifications are rejected.The open side of the returned pouch showed lacquer transfer in place and acceptable.This issue cannot be confirmed as a manufacturing defect.It is possible the pouch was opened in the distribution chain or with the end user.The manufacturing processes, procedures, complaint history and risk documentation have been reviewed, and no further escalation is deemed to be necessary at this time.The event type is anticipated, low risk and within acceptable occurrence levels.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: OPSITE INCISE 28X30CM CTN 10
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22682885
• Report Number: 8043484-2025-00078
• Device Sequence Number: 15869075
• Product Code: KGX
• UDI-Device Identifier: 05000223049874
• UDI-Public: 5000223049874
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 4987
• Device Lot Number: 202422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown