BEUDAMED
    FDA Adverse Event Summary report: N

    ELECTRODE

    MDR report key: 28998 · Received July 10, 1995

    Report

    Report Number
    28998
    Date Received
    July 10, 1995
    Report Date
    July 1, 1995
    Manufacturer
    SOMATICS, INC.
    Product Code
    BWK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SUSTAINED SUPERFICIAL BURN FROM LEFT TEMPORAL ELECTRODE DURING SHOCK TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRODE ELECTRODE BWK SOMATICS, INC. SOM1702-093-ECI

    Patients

    Seq Age Sex Outcome Treatment
    1 *