BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4924903 · Received July 20, 2015

    Report

    Report Number
    MW5044433
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 5, 2015
    Report Date
    April 10, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). HAIR FALLING OUT JOINT PAINS HEART FLUCTUATES FROM TIME TO TIME BRAIN FOG I CAN'T REMEMBER ANYTHING. CONSTIPATION BUTT PAINS ON MY RIGHT AND TAIL BONE NASTY TASTE IN MY MOUTH. NAUSEA GAS BREAKING OUT IN VAGINA. SEVERE PAINS IN LOWER STOMACH TO THE POINT I CAN NOT FUNCTION!! BIG BELLY I LOOK PREGNANT. HARD TO HEEL. LONG PERIOD CRAMPING SEVERELY BLOOD CLOTS . PAIN IS EXTREMELY SEVERE. U T I... ALL THE TIME. SLEEPY. BLEED DURING SEX . DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468383 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 26.000 YR Hospitalization| S