BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR

    MDR report key: 571600 · Received February 7, 2005

    Report

    Report Number
    1645337-2005-00001
    Event Type
    Other
    Date Received
    February 7, 2005
    Date of Event
    July 1, 2004
    Report Date
    February 1, 2005
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RECEIVED A COPY OF A LETTER WRITTEN BY THE PT - "FOR THE LAST 6 MONTHS, I'VE BEEN EXPERIENCING SICKNESS WITH A LOW IMMUNE SYSTEM. I WENT INTO THE DR.'S AND THEY SAID I HAVE EXTREMELY HIGH THYROID ANTIBODIES, OFF THE CHART HIGH. MY THYROID WACKED OUT AND I BEEN ON MEDICINE FOR IT. ALSO FOR THE LAST 6 MONTHS, I'VE BEEN EXPERIENCING SEVERELY PAINFUL BREASTS FOR MOST OF THE MONTH. I MAY HAVE 2-3 DAYS WHERE I'M RELIEVED OF ANY PAIN AT ALL. COULD THIS BE ASSOCIATED WITH THE IMPLANTS? THIS NEVER HAD BEEN AN ISSUE WITH ME PRIOR (TO) THE SURGERY OTHER THAN A FEW DAYS BEFORE BY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR GEL FILLED MAMMARY PROSTHESES FTR MENTOR * LT 230053

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other