BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4974682 · Received August 5, 2015

    Report

    Report Number
    MW5045108
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 1, 2012
    Report Date
    July 7, 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). IN 2011 RIGHT AFTER MY THIRD CHILD WAS BORN I DECIDED TO GET THE ESSURE. I DIDN'T EXPERIENCE ANY SYMPTOMS UNTIL A YEAR LATER, FOR THE LAST THREE YEARS MY SYMPTOMS HAVE INCLUDED... DEBILITATING HEADACHES ALMOST EVERYDAY, EXTREME ABDOMINAL PAIN, BLEEDING DURING AND AFTER INTERCOURSE, PAIN DURING AND AFTER INTERCOURSE, NUMBNESS AND TINGLING IN HANDS, FEET, ARMS, LEGS, BURNING SENSATION IN ABDOMEN, WEIGHT LOSS, WEIGHT GAIN, BLOATING, FATIGUE, MOOD SWINGS, UNEXPLAINED BRUISING, DIZZINESS AND HERE RECENTLY I'VE DEVELOPED AN ALLERGY TO DAIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515044 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 27.000 YR