BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLDTRACE FETAL SCALP ELECTRODE

    MDR report key: 7106746 · Received December 11, 2017

    Report

    Report Number
    1722684-2017-00010
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 17, 2017
    Report Date
    November 12, 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 · 0

    CLINICAL INNOVATIONS WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT TO FURTHER EVALUATE THE CAUSE.

    Description of Event or Problem · 0

    HOPSITAL NARRATIVE TRANSLATED TO ENGLISH: "IN THE LAST TWO WEEKS WE HAD COMPLICATIONS WITH THE SCALP ELECTRODE : - 1X WINDINGS LEFT WITH INFECTION - 1X LACERATION OF THE SKIN AFTER REMOVING. IN GENERAL WE ALL HAVE THE IMPRESSION THAT THE SCALP ELECTRODES ARE VERY DIFFICULT TO DETACH. IT IS FOR EXAMPLE AFTER A CAESAREAN SECTION OFTEN NOT POSSIBLE TO REMOVE THE ELECTRODE BY PULLING APART THE THREADS. THE NURSES ALSO HAVE THE FEELING THAT THE SPIRAL IS LONGER THAN BEFORE. THE LOT NUMBER OF THESE ELECTRODES IS 170347. WE WOULD LIKE TO RECEIVE YOUR REACTION TO THIS. CAN YOU ALSO LET US KNOW IF IT IS CORRECT THAT THE SPIRAL IS NOW LONGER THAN IN THE PAST? DO YOU HAVE AN INSTRUCTION TO REMOVE CORRECTLY THE SCALP ELECTRODE? MAYBE THE CUSTOMER CAN LEARN FROM THAT FOR THE FUTURE."

    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 INFOMRATION REGARDING THE INCIDENT.

    Description of Event or Problem · 1

    HOSPITAL NARRATIVE TRANSLATED TO ENGLISH: "IN THE LAST TWO WEEKS WE HAD COMPLICATIONS WITH THE SCALP ELECTRODE: -1X WINDING LEFT WITH INFECTION - 1X LACERATION OF THE SKIN AFTER REMOVING. IN GENERAL WE ALL HAVE THE IMPRESSION THAT THE SCALP ELECTRODES ARE VERY DIFFICULT TO DETACH. IT IS FOR EXAMPLE AFTER A CAESAREAN SECTION OFTEN NOT POSSIBLE TO REMOVE THE ELECTRODE BY PULLING APART THE THREADS. THE NURSES ALSO HAVE THE FEELING THAT THE SPIRAL IS LONGER THAN BEFORE. THE LOT NUMBER OF THESE ELECTRODES IS 170347. WE WOULD LIKE TO RECEIVE YOUR REACTION TO THIS. CAN YOU ALSO LET US KNOW IF IT IS CORRECT THAT THE SPIRAL IS NOW LONGER THAN IN THE PAST? DO YOU HAVE AN INSTRUCTION TO REMOVE CORRECTLY THE SCALP ELECTRODE? MAYBE THE CUSTOMER CAN LEARN FROM THAT FOR THE FUTURE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885519 GOLDTRACE FETAL SCALP ELECTRODE FETAL SPIRAL ELECTRODE HGP CLINICAL INNOVATIONS, LLC CNS00004 170347

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization