MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. LEUKOSTRIP 6.4X102MM CTN 50; TOPICAL APPROXIMATION SYSTEM

Catalog Number 66002879

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  Injury  

Event Description

It was reported that on multiple applications during a test, the leukostrip begin to lift up/roll upwards circa 1-2mm, after two hours.Leukostrip was removed and a competitor's product was used.There was no delay.No patient harm reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has been returned and evaluated.A visual and functional evaluation found no faults.There was no relationship between the device and the reported event and no root cause was determined.Probable cause includes, skin preparation and wound care, the ifu offers further guidance.Medical review concluded: no patient harm was reported, the steri-strips were used as replacements for the leukostrip.Since no adverse events are being reported due to the reported, no further medical assessment is warranted.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event in the past years.The associated risk files contain details relating to harm.However, no harm has been alleged.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.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: LEUKOSTRIP 6.4X102MM CTN 50
• Type of Device: TOPICAL APPROXIMATION SYSTEM
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10788379
• MDR Text Key: 214718215
• Report Number: 8043484-2020-03739
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66002879
• Device Lot Number: 1927A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1