BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4921249 · Received July 17, 2015

    Report

    Report Number
    MW5044212
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 10, 2011
    Report Date
    June 24, 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). SINCE HAVING ESSURE, I'VE EXPERIENCED MIGRAINE HEADACHES, CLOUDED VISION, BLURRED VISION, LOSS OF VISION, HEART CONDITION, STROKE, HEAVING BLEEDING, CRAMPING, BLOATING, STOMACH INFECTIONS, BACK PAIN, LEG, ARM JOINT PROBLEMS, MUSCLE SPASMS. SEVERAL HOSPITALIZATION, HYSTERECTOMY, REMOVAL OF GALLBLADDER, BLOOD CLOTS RESULTING IN LIFETIME BLOOD THINNERS. WEIGHT GAIN, LOSE OF SPEECH DUE TO STROKE. GASTROINTESTINAL PROBLEMS, HYPERACTIVE THYROID, ANXIETY, DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466459 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 41.000 YR Hospitalization| L| S