BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3233879 · Received July 13, 2013

    Report

    Report Number
    MW5030920
    Event Type
    Injury
    Date Received
    July 13, 2013
    Date of Event
    March 16, 2010
    Report Date
    July 13, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, I HAD THE ESSURE PROCEDURE DONE. EVER SINCE THEN MY BODY STARTED GIVING ISSUES THAT I HAVE NEVER HAD BEFORE. I HAVE ALWAYS BEEN THIN, AFTER ESSURE I WEIGH 165 AND MY STOMACH ALWAYS SWELLS UP MAKING ME LOOK LIKE I AM 5 MONTHS PREGNANT. I HAVE PAINS IN MY LOWER ABDOMEN, AND MY TOES CRAMP UP ONCE IN A WHILE. I GET DIZZY SPELLS AND INTERCOURSE IS ALWAYS PAINFUL. MY LOWER BACK ALSO HURTS FOR DAYS AT A TIME. SHARP PAINS DAILY ON MY RIGHT AND LEFT SIDES. I WENT TO THE DOCTOR AND THEY RELATED MY ISSUES TO IRRITABLE BOWEL SYNDROME AND GAVE ME PILLS FOR PAIN. I KNOW THIS IS NOT THE ISSUE BECAUSE I HAVE HAD THESE ISSUES EVER SINCE THE ESSURE COILS WERE INSERTED. I EAT RIGHT AND WORK OUT SO THERE IS NO REASON WHY MY STOMACH SWELLS UP THE WAY IT DOES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325194 ESSURE NONE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other