MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX; TAPE AND BANDAGE, ADHESIVE

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

It the study "does taping torso scars following dermatologic surgery improve scar appearance?", there were a total of 195 patients using leukostrip and or melolin & opsite dressings.Control group did not use leukostrip but interventioned group did.In this study there was 1 patient reporting dehiscence.It is unknown what kind of treatment was given.

Manufacturer Narrative

H3, h6: the device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the reported event or determine a root cause.The probable cause is application or product failure.The instructions for use has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.No batch/lot number has been provided, therefore a review of the device history has not been possible the complaint history file contains further instances.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

D1, d2a, d2b, d4, h3, h6: the product in the reported event was not returned for evaluation.A documentation review was performed for this event.A review of the batch records was not performed for this event as no batch lot number has been provided.A review of previous complaints found no other reports against opsite flexifix products relating to wound dehiscence, with no relevant previous escalations.With none considered as a result of this investigation.Technique guidelines for opsite flexifix products outline that the dressing is intended to be used as a secondary fixation in conjunction with a primary dressing, with the complaint product never intended to be used in direct contact with a wound.The study outlines that the product was used as intended.The associated risk files do not contain any detail of dehiscence when using this product.However, the clinical review has not established a causal link between the use of this device and the reported harm.The paper confirms that, not only was opsite flexifix used as a waterproof cover (not in direct contact with the wound or sutures), but it was also only used during the cooler months so not all participants received this dressing.The medical review goes on to confirm that, as the dressing was used as indicated, it is not likely that the opsite flexifix could have caused or contributed to the reported wound dehiscence.Based on all the information available, no updates to the relevant risk file are required.Probable cause of the reported wound dehiscence remains unknown, with potential factors unable to be provided, however it can be concluded that opsite flexifix did not contribute to the reported event.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.

• Brand Name: OPSITE FLEXIFIX
• 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: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10404683
• MDR Text Key: 202856052
• Report Number: 8043484-2020-02477
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 05/25/2021; 08/18/2023
• Supplement Dates FDA Received: 05/25/2021; 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention