BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDTRACE FETAL SCALP ELECTRODE

    MDR report key: 8191386 · Received December 21, 2018

    Report

    Report Number
    1722684-2018-00017
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    August 15, 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

    IT IS VERY IMPORTANT FOR THE FSE TO BE APPLIED CORRECTLY TO HAVE THE BEST RESULTS OF MONITORING AND REMOVAL AT THE END OF DELIVERY. IT IS IMPERATIVE THAT THE FSE NOT BE ROTATED MORE THAN 1 ½ TURN WHEN APPLYING IT TO THE BABY'S SCALP. IF THE ELECTRODE IS EXCESSIVELY TORQUED DURING (E.G. ROTATED > 1 ½ TURNS CLOCKWISE) APPLICATION TO THE PRESENTING PART OR IF THE ELECTRODE WAS ROTATED IN THE INCORRECT DIRECTION WHEN REMOVING FROM THE SCALP. THE INSTRUCTIONS FOR REMOVAL OF THE FSE IN THE IFU READS AS FOLLOWS: "REMOVE SPIRAL NEEDLE BY GRASPING ELECTRODE WIRES AS CLOSE TO FETAL PRESENTING PART AS POSSIBLE AND TWIST COUNTER-CLOCKWISE UNTIL FREE FROM PRESENTING PART". WHEN REMOVING THE FSE, IT IS VERY IMPORTANT TO MAKE SURE THAT THE CLINICIANS ARE TWISTING IT COUNTER-CLOCKWISE AS CLOSE TO THE PRESENTING PART, AS POSSIBLE. IF IT WAS INSERTED CORRECTLY, IT SHOULD NOT TAKE MORE THAN A 1 ½ TURN TO REMOVE IT. EDUCATION ON PROPER INSERTION AND REMOVAL ALONG WITH REVIEWING OF THE IFU'S ARE VERY IMPORTANT FOR ANY CLINICIAN USING THIS PRODUCT. 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

    AT THE DELIVERY WARD, SWELLING WAS NOTED ON THE CHILD'S SCALP, WHICH WAS JUDGED TO BE DUE TO THE ELECTRODE PREVIOUSLY SITTING THERE. THE SWELLING DID NOT RECEDE, AND WHEN THE CHILD WAS (B)(6), IT WAS EXAMINED THROUGH THE ULTRASOUND THAT SHOWED A SMALL METAL PIECE SUPERFICIALLY UNDER THE SKIN, ABOUT 4X1MM REPORTEDLY. THE CHILD HAS NO COMPLICATIONS BUT WILL BE FOLLOWED UP AT (B)(6) CLINIC WITH A VIEW TO REMOVING THE FOREIGN BODY BY LOCAL ANESTHESIA OR ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029638 GOLDTRACE FETAL SCALP ELECTRODE FETAL SCALP ELECTRODE HGP CLINICAL INNOVATIONS, LLC CNS000004

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other