BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SPIRAL ELECTRODE

    MDR report key: 9297535 · Received November 8, 2019

    Report

    Report Number
    1218950-2019-08523
    Event Type
    Injury
    Date Received
    November 8, 2019
    Date of Event
    October 31, 2019
    Report Date
    November 7, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGP
    UDI-DI
    20884838007431
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE PRODUCT WAS DISCARDED. AN EVALUATION WAS NOT COMPLETED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE PRODUCT WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COIL WAS REPORTED MISSING AFTER EXAMINATION. PEDIATRICIAN INSPECTED HEAD POST BIRTH AND WAS UNABLE TO LOCATE COIL. DAY 3 LUMP ON BABY'S HEAD DEVELOPED AND REMOVED ON WARD UNDER LOCAL ANESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095417 FETAL SPIRAL ELECTRODE FETAL SPIRAL ELECTRODE, SINGLE HGP PHILIPS MEDICAL SYSTEMS 989803137631 UNKNOWN 20884838007431

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA