BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILICONE BREAST IMPLANT

    MDR report key: 8293082 · Received January 29, 2019

    Report

    Report Number
    MW5083563
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    April 21, 2009
    Report Date
    January 28, 2019
    Manufacturer
    MENTOR (JOHNSON AND JOHNSON)
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SILICONE IMPLANT AND I¿M GETTING NO HELP FROM THE COMPANY. I WAS IN A STUDY WITH MENTOR AND MY LIFE IS AWFUL SINCE THESE IMPLANTS WERE PUT IN MY HEALTH ISSUES ARE SO BAD I WAS ROBBED A LIFE I HAD A FULL HYSTERECTOMY AT AGE (B)(6) PROFANITY NO ONE IS HELPING THEY ARE JUST CALLING ME CRAZY AND PUTTING ME ON MORE MEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80913 MENTOR SILICONE BREAST IMPLANT PROSTHESIS, BREAST, SILICONE GEL FILLED FTR MENTOR (JOHNSON AND JOHNSON) #267495
    80914 MENTOR SILICONE BREAST IMPLANT PROSTHESIS, BREAST, SILICONE GEL FILLED FTR MENTOR (JOHNSON AND JOHNSON)

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| O| R| S