BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE IMPLANTS

    MDR report key: 7850608 · Received September 5, 2018

    Report

    Report Number
    MW5079602
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2018
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LOW WBC, POSITIVE ANA, MONOCYTES ARE AT 13%. ENTIRE BODY IS INFLAMED, MASSIVE WEIGHT GAIN, BRAIN FOG, RINGING IN EARS, OUT OF NOWHERE HORRIBLE ALLERGIES, HAND AND WET SWELLING, KNEE/SHOULDER THROBBING, SKIN CONDITION ON KNEES, MAJOR FATIGUE, INFLAMED JOINTS, RASHES, PAINFUL BREASTS, AND MEMORY LOSS. TESTING NEGATIVE TO ALL DISEASE. MY BLOOD IS SCREAMING DISEASE AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688301 SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE FWM MENTOR TEXAS LP
    688302 SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE FWM MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| S