BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORA-QUICK

    MDR report key: 859344 · Received May 30, 2007

    Report

    Report Number
    MW5002139
    Event Type
    Injury
    Date Received
    May 30, 2007
    Date of Event
    May 17, 2007
    Report Date
    May 30, 2007
    Product Code
    MTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US

    Narratives

    Description of Event or Problem · 1

    MY BEST FRIEND TOOK AN ORA SURE SWAB TEST IN THE LOCAL GLB AND HE HAD A POSITIVE RESULT. AFTER MUCH CRYING AND SUICIDE CONTEMPLATION, HE WAS TOLD THAT THE TEST WAS A FALSE POSITIVE -CONFIRMED BY WESTERN BLOT BLOOD TEST-. THIS IS SUCH A CONCERN FOR HE DISCUSSED WITH FAMILY MEMBERS, FRIENDS AND LOVER ABOUT THE POSITIVE RESULTS. WHY IS THIS TEST ALLOWED ON THE MARKET???

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORA-QUICK ORA -SURE MTL

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| S