BEUDAMED
    FDA Adverse Event Summary report: N

    CONFIRM CLEARLY

    MDR report key: 811557 · Received January 31, 2007

    Report

    Report Number
    MW4004267
    Date Received
    January 31, 2007
    Date of Event
    October 5, 2006
    Report Date
    November 15, 2006
    Manufacturer
    MIZUHO USA, INC
    Product Code
    LCX
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER COMPLAINED THAT ON TWO PREGNANCY TESTS TAKEN ON DIFFERENT DATES STATED TO BE POSITIVE. CONSUMER HAD BLOOD WORK AT DR'S OFFICE TO CONFIRM PREGNANCY. THREE FALSE POSITIVE RESULTS WERE GIVEN BY THESE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIRM CLEARLY * LCX MIZUHO USA, INC * *
    2 CONFIRM CLEARLY * LCX MIZUHO USA, INC * LJ606

    Patients

    Seq Age Sex Outcome Treatment
    1 *