BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLD TRACE FETAL SCALP ELECTRODE

    MDR report key: 8016924 · Received October 29, 2018

    Report

    Report Number
    1722684-2018-00014
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    August 25, 2015
    Report Date
    October 24, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    UDI-DI
    00814247020505
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL INNOVATIONS LEARNED THROUGH OUR DISTRIBUTOR OF THIS EVENT THAT HAPPENED IN 2015. OUR DISTRIBUTOR RECEIVED A LETTER FROM THE HOSPITAL WHERE THE EVENT HAPPENED THAT WAS DATED (B)(6) 2018. WE ARE TRYING TO GATHER MORE INFORMATION IF ANY IS AVAILABLE.

    Description of Event or Problem · 1

    USE OF GOLDTRACE FSE CLAIMED TO HAVE PERMANENTLY CAUSED TISSUE DAMAGE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856548 GOLD TRACE FETAL SCALP ELECTRODE FETAL SCALP ELECTRODE HGP CLINICAL INNOVATIONS, LLC CSN000004 UKNOWN 00814247020505

    Patients

    Seq Age Sex Outcome Treatment
    1