BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE COILS

    MDR report key: 3704978 · Received March 24, 2014

    Report

    Report Number
    MW5035236
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    March 19, 2010
    Report Date
    March 21, 2014
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE ON (B)(6) 2010. I BEGUN TO EXPERIENCE LOST OF ENERGY AND FEELING VERY TIRED. I ALSO START TO HAVE GASTROINTESTINAL PROBLEMS DEVELOPING DIARRHEA FEW TIMES A WEEK. AS TIME WENT BY I DEVELOPED MORE SYMPTOMS SUCH AS HOT FLASHES, NAUSEA, DIZZINESS, SHARP STABBING PELVIC PAIN, MOOD CHANGES, WEIGHT GAIN, FORGETFULNESS, SEBACEOUS CYST WHICH HAD TO BE SURGICALLY REMOVED. I ALSO BEGUN TO EXPERIENCE SHORTNESS OF BREATH, TIGHTNESS IN CHEST FOR WHICH I HAD TO BE REFERRED TO SEE A PULMONARY SPECIALIST. I BEGUN TO GAIN WEIGHT, AND DEVELOPED WRIST PAIN FOR WHICH I HAD AND EMG / NCV COMBO NEURO AND IT SHOWED THAT I HAD DEVELOPED CARPAL TUNNEL SYNDROME. I WAS REFERRED TO SEE AN ORTHOPEDIC DOCTOR AND HE CONFIRM THAT I HAD CTS, SYNOVITIS OF WRIST AND GANGLION ON MY LEFT WRIST. I HAD TO USE HAND SPLINTS EVERY NIGHT AND SOME TIME DURING THE DAY. I ALSO EXPERIENCE VERY PAINFUL INTERCOURSE AND BLEEDING AFTER SEX. MY PERIODS WERE HEAVY AND I HAD BIG BLOOD CLOTS DURING MY PERIODS. I ALSO HAD THE SEVERE BLOATING, BLACK OUT SPELLS AND BLEEDING DURING PERIODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173475 ESSURE COILS ESSURE COILS HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention| S