MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN LEUKOSTRIP; TOPICAL APPROXIMATION SYSTEM

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

Patient Problem Unspecified Infection (1930)

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.It was reported that a patient developed infection.It is unknown what kind of treatment was given.

Manufacturer Narrative

The device used in treatment has not been returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Medical review concluded, the root cause of the reported infection and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Probable cause is inherent risk of infection from procedure.Indications; for primary and secondary closure of skin wounds.Used in the fixation of skin grafts.The instructions for use provide comprehensive instructions of the operation, use and limitations 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 rendering a review of the device history not possible.A complaint history review found other related failures.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.

• Brand Name: UNKN LEUKOSTRIP
• Type of Device: TOPICAL APPROXIMATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10405021
• MDR Text Key: 202856750
• Report Number: 8043484-2020-02489
• Device Sequence Number: 1
• Product Code: MZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention