BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS CLOTEST RAPID UREASE TEST SYSTEM

    MDR report key: 11854849 · Received May 19, 2021

    Report

    Report Number
    MW5101438
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 17, 2021
    Report Date
    May 17, 2021
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    LYR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LAB TEST SYSTEM; AVANOS CLOTEST RAPID UREASE TEST BEING MARKETED AS A WAIVED TEST - HOSPITALS UTILIZING AS A WAIVED TEST - CANNOT FIND THE TEST IN THE CLIA/FDA DATABASE - I DO HAVE A COPY OF THE PACKAGE INSERT (INSTRUCTIONS FOR USE). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742855 AVANOS CLOTEST RAPID UREASE TEST SYSTEM HELICOBACTER PYLORI LYR AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other