BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMNISURE RAPID FETAL MEMBRANES RUPTURE TEST

    MDR report key: 9172802 · Received October 8, 2019

    Report

    Report Number
    MW5090306
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    September 17, 2019
    Report Date
    October 7, 2019
    Manufacturer
    QIAGEN
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AMINISURE DONE, WHEN REMOVED THE COTTON TIP STAYED INSIDE, ATTEMPTED TO REMOVE BUT UNABLE TO. NOTIFIED MD, ORDERS TO DO SPECULUM EXAM, PT AWARE. SPECULUM EXAM COMPLETED WITH NEGATIVE RESULTS. POSSIBLY CAME OUT WHILE PT WAS VOIDING AND EXPELLED SOME CLOTS, BLEEDING RESEMBLING MUCOUS PLUG. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959341 AMNISURE RAPID FETAL MEMBRANES RUPTURE TEST IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S) NQM QIAGEN 56304378

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization