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

Model Number 66000714

Device Problem Biocompatibility (2886)

Patient Problems Itching Sensation (1943); Rash (2033); Ambulation Difficulties (2544); Skin Burning Sensation (4540); Swelling/ Edema (4577)

Event Date 04/07/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 290935461
• Report Number: 8043484-2022-00147
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223441395
• UDI-Public: 05000223441395
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 66000714
• Device Catalogue Number: 66000714
• Device Lot Number: 202138
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female