BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDTRACE FETAL SPIRAL ELECTRODE

    MDR report key: 7106754 · Received December 11, 2017

    Report

    Report Number
    1722684-2017-00006
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    July 21, 2017
    Report Date
    November 10, 2018
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION COULD BE OBTAINED FOR THIS REPORT. THE PRODUCT WAS DISCARDED AND FURTHER ASSESSMENT COULD NOT BE CONDUCTED NOT CONDUCTED.

    Description of Event or Problem · 0

    ON THE 21ST OF JULY 2017, A CAPUT ELECTRODE WAS PLACED DURING THE DELIVERY FOR FETAL MONITORING OF THE BABY. HOWEVER, DURING THE REMOVAL OF THE ELECTRODE, A PIECE OF METAL OF THIS ELECTRODE REMAINED STUCK UNDER THE SKIN OF THE BABY'S HEAD. THIS HAS BEEN PROVEN 20 DAYS AFTERWARDS THROUGH A RADIOLOGICAL EXAMINATION, BECAUSE OF A PAINFUL SWELLING ON THE HEAD. THE BROKEN PART HAS BEEN SURGICALLY REMOVED AFTERWARDS. INITIALLY ANOTHER SUPPLIER WAS NOTIFIED IN THIS CASE. AFTER INVESTIGATION, IT APPEARED HOWEVER THAT A SCALP ELECTRODE OF BMA (SCALP ELECTRODE GOLDTRACE) IS CONCERNED. THE COMPLAINT RELATES TO THE SCALP ELECTRODE WITH REFERENCE NUMBER: (B)(4). BECAUSE THIS INCIDENT WAS ONLY DIAGNOSED LATER ON, IT IS NOT CLEAR WHICH LOT NUMBER EXACTLY IS CONCERNED. THE LOT NUMBERS BEING IN THE HOSPITAL AT THE TIME OF THE SIGNALING ARE 170714 AND 170341.

    Additional Manufacturer Narrative · 1

    THIS HAS AN EXTREMELY RARE OCCURRENCE AND THIS TYPE OF FAILURE IS CAUSED BY USE ERROR OF THE PRODUCT EITHER WHEN PLACING THE DEVICE (OVER-ROTATION) AND/OR UPON REMOVING THE DEVICE (UNDER-ROTATION). CLINICAL INNOVATIONS IS TRYING TO GET MORE INFORMATION REGARDING THE INCIDENT.

    Description of Event or Problem · 1

    ON THE (B)(6) 2017, A CAPUT ELECTRODE WAS PLACED DURING THE DELIVERY FOR FETAL MONITORING OF THE BABY. HOWEVER, DURING THE REMOVAL OF THE ELECTRODE, A PIECE OF METAL OF THIS ELECTRODE REMAINED STUCK UNDER THE SKIN OF THE BABY'S HEAD. THIS HAS BEEN PROVEN 20 DAYS AFTERWARDS THROUGH A RADIOLOGICAL EXAMINATION, BECAUSE OF A PAINFUL SWELLING ON THE HEAD. THE BROKEN PART HAS BEEN SURGICALLY REMOVED AFTERWARDS. INITIALLY ANOTHER SUPPLIER WAS NOTIFIED IN THIS CASE. AFTER INVESTIGATION, IT APPEARED HOWEVER THAT A SCALP ELECTRODE OF BMA (SCALP ELECTRODE GOLDTRACE) IS CONCERNED. THE COMPLAINT RELATES TO THE SCALP ELECTRODE WITH REFERENCE NUMBER CNS000004. BECAUSE THIS INCIDENT WAS ONLY DIAGNOSED LATER ON, IT IS NOT CLEAR WHICH LOT NUMBER EXACTLY IS CONCERNED. THE LOT NUMBERS BEING IN THE HOSPITAL AT THE TIME OF THE SIGNALING ARE 170714 AND 170341.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885523 GOLDTRACE FETAL SPIRAL ELECTRODE FETAL SCALP ELECTRODE HGP CLINICAL INNOVATIONS, LLC CNS000004 170714

    Patients

    Seq Age Sex Outcome Treatment
    1 20 DA Required Intervention