BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3736734 · Received April 9, 2014

    Report

    Report Number
    MW5035551
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    November 1, 2011
    Report Date
    March 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH A MEDICAL DEVICE CALLED ESSURE ON (B)(6) 2011. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMERLY BY CONCEPTUS INC. MY LOT NUMBER IS 844600. MY MODEL NUMBER IS ESS305. THIS DEVICE HAS A THREE YEAR SHELF LIFE; HOWEVER, I DO NOT HAVE THE EXPIRATION DATE. THE ONSET OF MY COMPLAINT STARTED IN (B)(6) 2011. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE: MODERATE/CYSTIC ACNE, DIZZINESS, CHRONIC MIGRAINES, CHRONIC PELVIC PAIN, LOWER BACK PAIN, PAINFUL PERIODS, BREAK-THROUGH PERIODS, BLOATING, LOSS OF ENERGY, FIBROID MASS IN MY UTERUS, CYSTS IN MY OVARIES, AND THICKENING OF MY UTERINE LINING. I HAVE BEEN SEEN BY MY PCP AND REFERRED TO A GYNECOLOGIST. I HAVE BEEN DIAGNOSED WITH MIGRAINES, WHICH I AM CURRENTLY TAKING PROCHLORPERAZINE FOR. DYSMENORRHEA AND MENORRHAGIA HAVE BEEN ADDED TO MY LIST OF SYMPTOMS. I AM SCHEDULED FOR A HYSTERECTOMY ON (B)(6) 2014. THE DEVICE IS CURRENTLY STILL INSIDE ME.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON (B)(6) 2014: I HAD A SUCCESSFUL HYSTERECTOMY ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215468 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36.000 YR Disability ESSURE