BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUND TEC IMPLANT

    MDR report key: 563247 · Received January 3, 2005

    Report

    Report Number
    563247
    Event Type
    Injury
    Date Received
    January 3, 2005
    Date of Event
    November 17, 2004
    Report Date
    December 20, 2004
    Manufacturer
    SOUND TEC INC.
    Product Code
    FZD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANT OF SOUNDTEC PROSTHESIS WAS DONE 2002. THE PT REQUIRED SURGERY 2004 TO HAVE THE PROSTHESIS REMOVED DUE TO IT MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOUND TEC IMPLANT EAR PROSTHESIS FZD SOUND TEC INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization