BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROM PLUS COMPLETE KIT

    MDR report key: 7925985 · Received October 1, 2018

    Report

    Report Number
    MW5080250
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    July 29, 2018
    Report Date
    September 28, 2018
    Manufacturer
    CLINICAL INNOVATIONS EUROPE, LTD.
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ROM PLUS COMPLETE KIT, NOT ENOUGH LIQUID IN THE VIAL. ORIGINAL KIT DISCARDED, NEW ONE OBTAINED, NO NEGATIVE IMPACT TO PATIENT. ORIGINAL PACKAGING AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764973 ROM PLUS COMPLETE KIT IMMUNOASSAY FOR DETENTION OF AMNIOTIC FLUID PROTEIN(S) NQM CLINICAL INNOVATIONS EUROPE, LTD. ROM-5025 180484

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR