BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLMAN SURGITRON

    MDR report key: 134283 · Received November 25, 1997

    Report

    Report Number
    2428235-1997-00001
    Event Type
    Injury
    Date Received
    November 25, 1997
    Date of Event
    January 31, 1996
    Report Date
    November 24, 1997
    Manufacturer
    ELLMAN INTERNATIONAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LEEP PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELLMAN SURGITRON RADIOSURGERY GENERATOR GEI ELLMAN INTERNATIONAL, INC. F.F.P.F. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization COOPERS SURGICAL SPECULUM.