MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE INCISE 10X14CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Model Number	4963, 4975
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Local Reaction (2035)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during usage of opsite dressing to treat a broviac central line, patient experienced a significant reaction to the area were the dressing was applied.Patient received triamcinolone and bactrim as a treatment, and also was swab to make sure skin was not infected.Patient also required an dermatology appointment.The usage of opsite dressing was suspended and was replaced for gauze over the area, within two days after the dressing suspension, the skin was back to normal.Patient outcome is unknown.
Additional Manufacturer Narrative
The device used in treatment has not been returned for evaluation.It was reported that during usage of opsite dressing to treat a broviac central line, patient experienced a significant reaction to the area were the dressing was applied.The photo provided confirms a relationship between the device and the reported event.However, a root cause could not be determined by viewing the photo.Probable root cause is incorrect skin preparation, incorrect dressing application or the patient experienced a reaction to one or more of the components of the dressing.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct skin preparation technique and dressing application.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A review of complaint history did not reveal similar events for the listed batch and part number with no manufacturing problems observed.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A clinical/medical assessment was performed and determined no further actions are required.A review of prior escalation actions found no actions applicable to the scope of this case.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 10X14CM CTN 50
• 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: 12806625
• Report Number: 8043484-2021-01955
• Device Sequence Number: 5484709
• Product Code: KGX
• UDI-Device Identifier: 05000223415464
• UDI-Public: 05000223415464
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4963, 4975
• Device Catalogue Number: 4975
• Device Lot Number: 202103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 08/03/2022
• 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