BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOJRAB ALTO TOTAL OR PARTIAL PROSTHESES

    MDR report key: 1193295 · Received October 7, 2008

    Report

    Report Number
    1057421-2008-00001
    Event Type
    Injury
    Date Received
    October 7, 2008
    Report Date
    September 8, 2008
    Manufacturer
    GRACE MEDICAL, INC.
    Product Code
    ETA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT HE HAS REVISED 5 BOJARB ALTO PROSTHESES. THE SURGEON REPORTED THAT PTS WITH PERFECT HEARING BEGAN TO COMPLAIN OF A TINNY SOUND AND SOME HAD ABNORMAL TISSUE GROWTH. THE PROSTHESES WERE REVISED. THIS IS THE FIRST OF FIVE MEDWATCH REPORTS TO BE FILED REGARDING THIS REPORT. IF ADD'L INFO IS RECEIVED, IT WILL BE EVALUATED FOR A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOJRAB ALTO TOTAL OR PARTIAL PROSTHESES OSSICULAR PROSTHESES, TOTAL OR PARTIAL ETA GRACE MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention