BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR IMPLANTS

    MDR report key: 8612139 · Received May 14, 2019

    Report

    Report Number
    MW5086641
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    May 14, 2009
    Report Date
    May 13, 2019
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I FEEL LIKE DEATH, I HAVE 5 AUTOIMMUNE DISEASES AND I AM WEAK. I HAVE PAIN IN MY NECK AND UPPER BACK, BREAST. I CANNOT SWIM, I FEEL LIKE I CAN'T BREATHE AT THE TIME, I AM LIVING HELL AND THE DR CANNOT TELL ME WHY I AM NOT GETTING BETTER. THE LONGER THE DIRTY IMPLANTS ARE IN ME THE MORE I AM GETTING WEAK. I WILL HAPPILY GIVE ALL MEDICAL RECORD, JUST PLEASE STOP LETTING US BE TOLD WE NEED IMPACT. I WAS BORN WITH NIPPLES, NO BREAST TISSUE, AND IT WAS SAD FOR ME, SO I WENT TO SEE WHAT COULD BE DONE AT AGE (B)(6). THE DR TOLD ME I NEED IMPLANTS AND LIFT. NIPPLE REMOVAL AND REPLACEMENT NOW I AM SLOWLY DYING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403552 MENTOR IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC
    403553 MENTOR IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Disability