BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMNISURE RAPID FETAL MEMBRANES RUPTURE TEST

    MDR report key: 9219588 · Received October 21, 2019

    Report

    Report Number
    MW5090539
    Event Type
    Malfunction
    Date Received
    October 21, 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

    AMNISURE 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 RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006960 AMNISURE RAPID FETAL MEMBRANES RUPTURE TEST IMMUNOASSAY FOR DETECTING OF AMNIOTIC FLUID NQM QIAGEN 56304378

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other