BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL ELECTRODE

    MDR report key: 19139 · Received January 25, 1995

    Report

    Report Number
    MW1004867
    Event Type
    Malfunction
    Date Received
    January 25, 1995
    Date of Event
    November 5, 1994
    Report Date
    January 10, 1995
    Manufacturer
    COROMETRICS MEDICAL SYSTEMS, INC.
    Product Code
    HGP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DR ATTEMPTED TO ATTACH SCALP ELECTRODE. ON FIRST ATTEMPT, CORD WAS RETRACTED WITHOUT SPIRAL ATTACHED. DR REAPPLIED WITH ANOTHER ELECTRODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *