BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CORP

    MDR report key: 5260625 · Received November 27, 2015

    Report

    Report Number
    MW5058213
    Event Type
    Injury
    Date Received
    November 27, 2015
    Date of Event
    November 28, 2006
    Report Date
    November 27, 2015
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006, I HAD SILICONE GEL-FILLED BREAST IMPLANTS. THIS YEAR WHEN I MADE AN APPOINTMENT FOR A MAMMOGRAM, I LET THEM KNOW THAT I COULD FEEL SOMETHING WASN'T RIGHT AND THAT I FELT LOT OF PHYSICAL THINGS WRONG WITH ME, SO I WAS GIVEN AN MRI. IT SHOWED THAT ONE IMPLANT WAS DEFINITELY RUPTURED, DOCTOR TOOK THEM OUT ON (B)(6) 2015. AFTER SURGERY, MY DOCTOR TOLD ME THAT BESIDES THE RUPTURED IMPLANT, THE OTHER ONE WAS LEAKING. THERE IS NOT ANY REASON WHY MY IMPLANT SHOULD HAVE RUPTURED, I WAS NEVER IN ANY KIND OF ACCIDENT AND NO TRAMA TO MY BREAST WHATSOEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783169 MENTOR CORP BREAST IMPLANT FTR MENTOR 5647047
    783170 MENTOR CORP BREAST IMPLANT FTR MENTOR 5647047

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability