MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 55X45CM CTN 10; TAPE AND BANDAGE, ADHESIVE

Model Number	4989
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number case (b)(4).
Event or Problem Description
It was reported that, the sealing of an opsite incise 55x45cm ctn 10 was broken before use.It is unknown whether this problem was noticed in a therapeutic environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The photos provided confirms a relationship between the device and the reported event.Visual inspection of the complaint photos observed lacquer transfer is good, which confirms that there was no issue with sealing.The product was opened after sealing.A manufacturing process review was carried out.The manufacturing process has camera detection to remove the unsealed products.If the operator needs to check the seal, they will completely peel off the sealed side of the pouch, which will not cause the same situation as the complaint sample.Probable causes may include compression bursts during transportation or handling.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review revealed a small number of similar events for this nature with no manufacturing problems observed.A review of prior escalation actions found no actions applicable to the scope of this case.A risk management review concluded that the alleged failure mode has been anticipated within the risk file, with no updates required.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE INCISE 55X45CM 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17263618
• Report Number: 8043484-2023-00044
• Device Sequence Number: 12276677
• Product Code: KGX
• UDI-Device Identifier: 05000223415525
• UDI-Public: 05000223415525
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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
• Device Model Number: 4989
• Device Catalogue Number: 4989
• Device Lot Number: 202210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown