BEUDAMED
    FDA Adverse Event Summary report: N

    AMNISURE ROM TEST

    MDR report key: 2326060 · Received October 27, 2011

    Report

    Report Number
    2326060
    Date Received
    October 27, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 13, 2011
    Manufacturer
    AMNISURE INTERNATIONAL
    Product Code
    NQM
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS SUSPECTED OF SPONTANEOUS RUPTURE OF MEMBRANES. THE TEST RESULT WAS NEGATIVE. THE PATIENT CAME BACK SIX HOURS LATER FEBRILE AND POSITIVE CHORIOAMNIONITIS. THERE ARE TWO POSSIBLE LOT NUMBERS AND BOTH ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMNISURE ROM TEST NON-INSTRUMENTED QUALITATIVE IMMUNOCHROMATOGRAPHIC NQM AMNISURE INTERNATIONAL * A1003
    2 AMNISURE ROM TEST NON-INSTRUMENTED QUALITATIVE IMMUNOCHROMATOGRAPHIC NQM AMNISURE INTERNATIONAL * 80005

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR