BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE IMPLANTS

    MDR report key: 2781815 · Received October 4, 2012

    Report

    Report Number
    MW5027181
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    June 25, 2008
    Report Date
    October 4, 2012
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE DOING ESSURE PROCEDURE, I HAVE HAD AN EXTREME WEIGHT GAIN, LOWER BACK PROBLEMS AND IRREGULAR PERIODS. I AM EITHER BLEEDING SO BAD AND PASSING BLOOD CLOTS THAT I HAVE TO CHANGE CLOTHES THROUGHOUT THE DAY OR IT IS VERY LIGHT BUT IS BROWN MUCUS. I HAVE PINCHING SENSATIONS AND ABSOLUTELY NO SEX DRIVE. I HAVE ALSO HAD VERY BAD HEADACHES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR