BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN LEUKOSTRIP

    MDR report key: 10405349 · Received August 13, 2020

    Report

    Report Number
    8043484-2020-02492
    Event Type
    Injury
    Date Received
    August 13, 2020
    Report Date
    December 14, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    MZR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 1

    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. IT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868087 UNKN LEUKOSTRIP TOPICAL APPROXIMATION SYSTEM MZR SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention