BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDTEC IMPLANT

    MDR report key: 563248 · Received January 3, 2005

    Report

    Report Number
    563248
    Event Type
    Injury
    Date Received
    January 3, 2005
    Date of Event
    December 15, 2004
    Report Date
    December 20, 2004
    Manufacturer
    SOUNDTEC 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 EAR PROSTHESIS WAS DONE 2002. THE PT REQUIRED SURGERY 2004 TO HAVE THE PROSTHESIS REMOVED DUE TO IT MALFUNCTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization