BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3629182 · Received February 10, 2014

    Report

    Report Number
    MW5034487
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    June 1, 2010
    Report Date
    February 9, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER BEING IMPLANTED WITH THE PERMANENT BIRTH CONTROL DEVICE CALLED ESSURE, I STARTED HAVING ADVERSE EFFECTS 6 MONTHS LATER. THE PROBLEMS HAVE INCREASED EVER SINCE. I NOW SUFFER FROM A REOCCURRING STABBING PAIN IN MY BELLY BUTTON THAT LASTS FOR 10 DAYS EACH MONTH, EAR RINGING, FATIGUE, SWOLLEN/SOR TOES, SWIMMY HEAD, BLOATED, VITAMIN DEFICIENCY, THYROID, CONSTIPATION, NUMBNESS IN FINGERS, HEADACHES, BRAIN FATIGUE AND EYE WEAKNESS. SOME OF THESE SYMPTOMS COME AND GO, OTHERS ARE CONSTANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87569 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability