BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THYMATRON SYSTEM IV

    MDR report key: 1993062 · Received February 10, 2011

    Report

    Report Number
    MW5019406
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ECT TREATMENT, ELECTRODE OVER LEFT FRONTAL AREA OF PT'S HEAD CURLED OVER WHERE THE WIRE ATTACHES TO THE PAD AND THERE WAS A BURNING ODOR NOTED. UPON REMOVAL OF THE PAD, A WHITE LINE WAS NOTED ON THE PT'S FOREHEAD, ABOUT 1/2 INCH LONG SILVADENE CREAM WAS APPLIED TO THE PT'S FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THYMATRON SYSTEM IV ELECTRODE GXC SOMATICS, LLC 031617

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other