BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QU PID PREGNANCY TEST

    MDR report key: 32167 · Received April 22, 1996

    Report

    Report Number
    MW1008934
    Event Type
    Malfunction
    Date Received
    April 22, 1996
    Manufacturer
    STANBIO LAB,INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR HAD 2 BOXES WITH SAME LOT # AND EXP DATE. ONE BOX WAS HALF USED AND THERE WERE NO PROBLEMS. ON 4/10/96 SEVERAL (3) FROM THE ORIGINAL BOX WOULD NOT ABSORB THE SPECIMEN. SO A NEW BOX WITH THE SAME LOT # AND EXP DATE WAS OPENED AND THREE HAD SAME PROBLEM. RPTR OPENED A NEW BOX WITH NEW LOT # AND EXP DATE. RPTR HAD SAME PROBLEM WITH ONE OF 4 USED. OTHER 3 WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QU PID PREGNANCY TEST PREGNANCY TEST JHJ STANBIO LAB,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO