BEUDAMED
    FDA Adverse Event Other Summary report: N

    5MM DISPOSABLE BALL ELECTRODE

    MDR report key: 258195 · Received January 11, 2000

    Report

    Report Number
    2428235-1999-00002
    Event Type
    Other
    Date Received
    January 11, 2000
    Date of Event
    July 21, 1999
    Report Date
    December 22, 1999
    Manufacturer
    ELLMAN INTERNATIONAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING TONSILLECTOMY PROCEDURE, THE SHAFT OF DISPOSABLE ELECTRODE BALL SLIGHTLY BURNED RIGHT CORNER OF PT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM DISPOSABLE BALL ELECTRODE DISPOSABLE ELECTRODE GEI ELLMAN INTERNATIONAL INC. W18D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other VALLEYLAB FORCE 4B ELECTROSURGICAL UNIT.