BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT

    MDR report key: 8311495 · Received February 5, 2019

    Report

    Report Number
    MW5083759
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    January 1, 2015
    Report Date
    February 3, 2019
    Manufacturer
    MENTOR
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I¿VE HAD IMPLANTS FOR 13 YEARS. ROUGHLY 4 YEARS AGO I STARTED FEELING A DECLINE IN MY HEALTH FOLLOWING MY THIRD PREGNANCY. I ATTRIBUTED IT ALL TO BEING (B)(6) YEARS OLD AND HORMONES OUT OF WHACK. MY HAIR WAS FALLING OUT IN CLUMPS. IT HASN¿T GROWN BACK IN. I¿M EXTREMELY TIRED EVERY DAY. I HAVE DRY EYES, DARK CIRCLES, AND RED CAPILLARIES ALL THE TIME. MY MEMORY IS HORRENDOUS. IT¿S CALLED BRAIN FOG. I CAN¿T EVEN REMEMBER MOVIE PLOTS ANYMORE. I¿VE ALSO PUT ON WEIGHT WHICH I¿VE BLAMED ON PREGNANCIES AND AGE. THERE¿S JUST NO ENERGY FOR EXERCISE. IT¿S A BATTLE. MY IMMUNE SYSTEM SEEMS WEAKER THAN MY FAMILY MEMBERS. I GET SICK MORE FREQUENTLY AND HOLD ONTO THEM LONGER. SINUS INFECTIONS AND COLDS. MY THYROID WAS TESTED BY MY DOCTOR AND FOUND TO BE NORMAL. BECAUSE MY TESTS WERE NORMAL, I TRULY BELIEVED I WAS GETTING OLD, TIRED, AND FORGETFUL. THIS HAS BEEN GOING ON FOR 4 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101708 SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE KWM MENTOR 350 5632856
    101724 SMOOTH ROUND MODERATE PROFILE SALINE IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE KWM MENTOR 350 5632856

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Disability