BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROM + COMPLETE KIT

    MDR report key: 8793899 · Received July 15, 2019

    Report

    Report Number
    MW5088156
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 12, 2019
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    NQM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROM+ WAS ALREADY "POPPED" WHEN OPENED. LOT #190318. WAS NOT USED FOR PT CARE. RECOGNIZED ISSUE PRIOR TO USE. NO HARM TO PT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585706 ROM + COMPLETE KIT IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S) NQM CLINICAL INNOVATIONS, LLC ROM-5025 190318

    Patients

    Seq Age Sex Outcome Treatment
    1