BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUN MICROSYSTEMS/SHELL UNIX

    MDR report key: 545402 · Received June 20, 2004

    Report

    Report Number
    MW1032646
    Event Type
    Injury
    Date Received
    June 20, 2004
    Date of Event
    December 24, 1997
    Report Date
    June 30, 2004
    Manufacturer
    SUN MICROSYSTEMS, INC.
    Product Code
    MCM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A SYMPHONIX DEVICE, A TOTAL COCHLEAR/EYE/TOOTH/IMPLANT, TRAP AND TRACE, AVAILABLE THROUGH SUN MICROSYSTEMS, INC./SHELL UNIX WAS IMPLANTED WITHOUT PT REQUEST OR INFORMED CONSENT BY MEMBERS OF A FAMILY FOR CRIMINAL PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUN MICROSYSTEMS/SHELL UNIX VIBRANT SOUNDBRIDGE/TOTAL IMPLANT/COMPLETE SYSTEM MCM SUN MICROSYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening| S SEVERAL FOR SEVERE OTITIS MEDIA.