BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4253539 · Received November 8, 2014

    Report

    Report Number
    MW5039048
    Event Type
    Injury
    Date Received
    November 8, 2014
    Date of Event
    November 10, 2009
    Report Date
    November 8, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH ESSURE IN 2009 AND AFTER YEARS OF HORRIBLE PELVIC PAIN, BLEEDING, HEADACHES, VITAMIN D DEFICIENCY, LOWER BACK PAIN, DEPRESSION, IRREGULAR MENSTRUAL CYCLES LASTING MORE THAN THREE MONTHS, SIGNIFICANT UNEXPLAINABLE WEIGHT GAIN, AND AN INCREASE IN BLOOD PRESSURE, I AM NOW HAVING A HYSTERECTOMY AT THE AGE OF 34 TO RESOLVE THOSE ISSUES. AT THE TIME OF SURGERY, IT WILL BE DETERMINED IF THERE ARE ANY OTHER ISSUES, SUCH AS ENDOMETRIOSIS, THAT EXIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721138 ESSURE ESSURE HHS BAYER ESS305 626626

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability