BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRO MED

    MDR report key: 771907 · Received October 19, 2006

    Report

    Report Number
    MW1040739
    Event Type
    Malfunction
    Date Received
    October 19, 2006
    Report Date
    September 28, 2006
    Manufacturer
    Q.I MEDICAL INC
    Product Code
    JTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ASEPTIC TEST ALL SHOWED A GROWTH OF 1 OR 2 STRANDS OF WHAT WE THOUGHT WAS BACTERIA AND LATER FOUND OUT WAS THE ACTUAL PLASTIC OF THE BAG. WE TESTED 50 PEOPLE, THE FIRST TIME ONLY 2 "PASSED." THE SECOND TESTING WE TESTED 14 PEOPLE AND ONLY 1 "PASSED." THE CO SAID THAT IT WAS AN ERROR IN THE ACTUAL MFG OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRO MED PERSONAL ASEPTIC TECHNIQUE TEST JTO Q.I MEDICAL INC GM7030 50906P
    2 GRO MED PERSONAL ASEPTIC TECHNIQUE TEST JTO Q.I MEDICAL, INC. * 08206P

    Patients

    Seq Age Sex Outcome Treatment
    1 *