BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDTRACE

    MDR report key: 7125185 · Received December 18, 2017

    Report

    Report Number
    1722684-2017-00016
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Report Date
    December 18, 2017
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE INVESTIGATING THE COMPLAINT AND GATHERING MORE INFORMATION TO DETERMINE WHAT HAS CAUSED THE TIP TO BRAKE. WE ARE TRYING TO LOCATE THE DEVICE TO DO AN INVESTIGATION.

    Description of Event or Problem · 1

    DURING THE REMOVAL OF THE FSE, A PIECE OF THE SPIRAL NEEDLE OF THIS ELECTRODE REMAINED STUCK UNDER THE SKIN OF THE BABY'S HEAD. THE PIECE REMAINED THERE FOR 2 MONTHS. THE BROKEN PART HAD TO BEEN SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905902 GOLDTRACE FETAL SPIRAL ELECTRODE HGP CLINICAL INNOVATIONS, LLC CNS000004

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization