BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONICA HEALTHCARE FETAL MONITOR

    MDR report key: 8138801 · Received December 5, 2018

    Report

    Report Number
    MW5081891
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 3, 2018
    Manufacturer
    MONICA HEALTHCARE LTD.
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ELECTRODES LEFT AN INFLAMED, REDDENED AREA WHERE THEY HAD BEEN PREVIOUSLY PLACED ON THE PREGNANT WOMAN'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974123 MONICA HEALTHCARE FETAL MONITOR SYSTEM, MONITORING, PERINATAL HGM MONICA HEALTHCARE LTD. GTIN(01) 05060433670053 (10) 500871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other