BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2232286 · Received August 27, 2011

    Report

    Report Number
    MW5021936
    Event Type
    Injury
    Date Received
    August 27, 2011
    Date of Event
    June 17, 2010
    Report Date
    August 27, 2011
    Manufacturer
    ESSURE
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE AND NOW HAVE TO LIVE WITH A TOTAL CHANGE IN MY LIFE!!! I WENT FROM A VERY HEALTHY ACTIVE FIT WOMAN TO A WOMAN WITH LITTLE OR NO ENERGY. I CANNOT GO THROUGHOUT THE DAY WITHOUT A NAP BECAUSE I AM ALWAYS DRAINED. I NOW HAVE BAD MIGRAINES, LOWER BACK PAIN, SHARP PAINS IN STOMACH THAT IS UNBEARABLE AND UNEXPLAINED EXCESSIVE WEIGHT GAIN. I HAVE WENT FROM A (B)(6) TO A (B)(6) IN LESS THAN A YEAR. I HAVE NEVER HAD ANY PROBLEM WITH WEIGHT GAIN OR FEELING SO TIRED ALL THE TIME! I JUST WANT MY LIFE BACK!!! I WISHED I WOULD HAVE NEVER HAD THE ESSURE PROCEDURE DONE IT HAS RUINED MY LIFE!!!

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other ESSURE