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

Catalog Number UNKNOWN

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

Patient Problems Fever (1858); Unspecified Infection (1930); Urinary Tract Infection (2120); Dysuria (2684)

Event Type  Injury  

Event Description

It was reported in the publication "off-label-use of sulfur-hexafluoride in voiding urosonography for diagnosis of vesicoureteral reflux in children: a survey on adverse events" that the leukostrips (smith & nephew) dressing was applied to 531 patients, one of these patients presented a new onset dysuria and mild fever, most likely due to an acute episode of chronic uti.

Manufacturer Narrative

H10: h3, h6: the device, used in treatment, has not been returned for evaluation.The information provided by way of literature review has been performed, following this evaluation we have not been able to establish a relationship between the device and the event reported or determine a root cause on this occasion.No batch/lot details have been provided, due to this we are unable to conduct a review of the device history, however at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The complaint history review found further instances reported in the past years.Our medical/clinical review concluded: the data presented in the aged article on, ¿off-label-use of sulfur-hexafluoride in voiding urosonography for diagnosis of vesicoureteral reflux in children: a survey on adverse events," did not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded.No further medical assessment is warranted at this time.The risk files for leukostrip have been reviewed and contain multiple causes of local infection.Without further information, the failure mode relating to this complaint cannot be narrowed down any further.The ifu reviewed provides adequate instructions on the operation and use of the product, users are advised to select the most appropriate size according to clinical needs.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN LEUKOSTRIP
• 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: 10405353
• MDR Text Key: 202856866
• Report Number: 8043484-2020-02493
• 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: 12/14/2020

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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other