BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDTRACE FETAL SCALP ELECTRODES

    MDR report key: 8191387 · Received December 21, 2018

    Report

    Report Number
    1722684-2018-00019
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED; THE LOT NUMBER IS NOT KNOWN. NO FURTHER INFORMATION WILL BE MADE AVAILABLE BUT CLINICAL INNOVATIONS WILL CONTINUE TO MONITOR AND TREND ALL REPORTED EVENTS ASSOCIATED WITH THIS DEVICE.

    Description of Event or Problem · 1

    PROBLEMS REMOVING THE FETAL SCALP ELECTRODES. ACCORDING TO THE MIDWIFES THE SCALP ELECTRODES SEEMS MORE TIGHT THAN PREVIOUS BATCH. DEVICE CAUSED BIG BALD SPOTS AFTER PLACING THE SCALP ELECTRODES THREE-TIMES. THEY SAW 5 BABIES WITH INFLAMMATIONS DUE TO SCALP ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029640 GOLDTRACE FETAL SCALP ELECTRODES FETAL SCALP ELECTRODES HGP CLINICAL INNOVATIONS, LLC CNS000004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other