MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 25X10CM CTN 20; TAPE AND BANDAGE, ADHESIVE

Model Number	66000714
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Ambulation or Postural Difficulties (2544); Skin Burning Sensation (4540); Swelling/ Edema (4577)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tkr performed on (b)(6) 2022, the patient was discharged from the hospital following the application of a new opsite post op 25x10cm dressing.Within hours, she began to experience a painful rash and an intense burning and itching sensation under the adhesive part of the dressing and later migrating all over her body, especially on her arms and legs.The dressing was removed, a steroid cream and antihistamine tablets were prescribed, but the symptoms have persisted even 2 weeks after the initial reaction.In addition, the patient has been experiencing swelling of both legs, and a skin appearance reported as tight and shiny.Besides these symptoms, the wound has healed extremely well and very quickly and the doctors say this must be a severe allergic reaction and that it was from the adhesive on the dressing where the irritation started.
Additional Manufacturer Narrative
H3, h6: 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.The device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to confirm a relationship between the device and the reported event or determine a root cause.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.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 the clinical/medical evaluation concluded that based on the information provided it cannot be concluded that the events/clinical reactions were associated with the use of opo product.This investigation is now complete, with no additional corrective actions deemed necessary.Smith and nephew will continue to monitor for adverse trends relating to this product range.Internal complaint reference number: (b)(4).

• Brand Name: OPSITE POST OP 25X10CM CTN 20
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14291349
• Report Number: 8043484-2022-00147
• Device Sequence Number: 1532958
• Product Code: KGX
• UDI-Device Identifier: 05000223441395
• UDI-Public: 05000223441395
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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 Expiration Date: 09/01/2026
• Device Model Number: 66000714
• Device Catalogue Number: 66000714
• Device Lot Number: 202138
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female