BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SALINE SMOOTH ROUND

    MDR report key: 7805683 · Received August 21, 2018

    Report

    Report Number
    MW5079309
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    October 15, 2003
    Report Date
    August 17, 2018
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER GETTING MENTOR SALINE BREAST IMPLANTS I HAD TO QUIT MODELING AND MY OTHER WORK SUFFERED AS WELL. I STARTED DEVELOPING HORRIBLE GI ISSUES. ALLERGIES INCREASED, SINUS INFECTIONS, UTI AND KIDNEY INFECTIONS; HORMONAL IMBALANCE, LOWERED IMMUNE SYSTEM, SICK ALL THE TIME, AND JOINT PROBLEMS. I SPENT (B)(6) WITH DRS AND SPECIALISTS TO FIGURE OUT WHAT WAS CAUSING THE ROOT OF ALL OF MY SYMPTOMS AND I WAS ONLY IN MY 20S. WAS SUPER HEALTHY PRIOR TO IMPLANTS. I HAD CHRONIC INFLAMMATION THAT WAS ALWAYS ON MY BLOOD WORK THAT NO DR COULD PIN POINT. I DID UPPER GI AND COLONOSCOPY. I HAD HORRIBLE FOOD SENSITIVITIES TOO. OBGYN: STRANGE DISCHARGE FROM BREASTS AND LUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641347 MENTOR SALINE SMOOTH ROUND PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR
    641348 MENTOR SALINE SMOOTH ROUND PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention| S