BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLMAN SURGITRON EMC

    MDR report key: 365696 · Received December 12, 2001

    Report

    Report Number
    2428235-2001-00001
    Event Type
    Injury
    Date Received
    December 12, 2001
    Date of Event
    December 1, 2000
    Report Date
    December 11, 2001
    Manufacturer
    ELLMAN INTL., INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT'S PALATE WAS PERFORATED DURING VOLUMETRIC TISSUE REDUCTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56005 ELLMAN SURGITRON EMC RADIOSURGERY GENERATOR GEI ELLMAN INTL., INC. EMC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Disability