BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY GEL BREAST IMPLANTS

    MDR report key: 1212067 · Received October 23, 2008

    Report

    Report Number
    1645337-2008-00051
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    October 21, 2008
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT# 5592590.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH BILATERAL BREAST IMPLANTS IN 1971 DURING A BREAST AUGMENTATION PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH SJORGEN'S DISEASE, AND AUTO-IMMUNE THYROID DISEASE. THE IMPLANTS REMAIN IMPLANTED, AND NO DEVICE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEMORY GEL BREAST IMPLANTS MAMMARY PROSTHESIS FTR MENTOR 5573107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other