BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SPIRAL ELECTRODE

    MDR report key: 4297397 · Received November 24, 2014

    Report

    Report Number
    1218950-2014-07095
    Event Type
    Injury
    Date Received
    November 24, 2014
    Report Date
    November 19, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    HGP
    PMA / PMN Number
    K030691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBERS: 140833; EXP DATE: 01/01/2017: 140669; EXP DATE: 12/01/2016. (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING DELIVERY, THE METAL SPIRAL (COIL) OF THE (B)(4) FETAL SPIRAL ELECTRODE (FSE) BROKE OFF IN THE INFANTS SCALP. THE PIECE OF THE SPIRAL HAS TO BE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762106 FETAL SPIRAL ELECTRODE HGP PHILIPS MEDICAL SYSTEMS 989803137631 140989

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention