BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FETAL SCALP ELECTRODE

    MDR report key: 11655 · Received February 23, 1994

    Report

    Report Number
    11655
    Event Type
    Injury
    Date Received
    February 23, 1994
    Date of Event
    January 31, 1994
    Report Date
    February 2, 1994
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    HGP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RETAINED FETAL SCALP ELECTRODE TO FETAL HEAD. REMOVED SURGICALLY WITHOUT COMPLICATION. FSE APPRENTLY BEING USED TO RUPTURE MEMBRANES CONCURRENTLY WITH FSE PLACEMENT. TWO PROCEDURES DONE, USING TWO SEPERATE SPIRAL ELECTRODES; UNSURE WHICH RESULTED IN RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FETAL SCALP ELECTRODE HGP COROMETRICS MEDICAL SYSTEMS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Required Intervention