BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3131173 · Received May 22, 2013

    Report

    Report Number
    MW5030292
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    May 29, 2008
    Report Date
    May 22, 2013
    Manufacturer
    CONCEPTUS, INC
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTED WITH THE ESSURE COILS ON (B)(6) 2008. SINCE THE PROCEDURE, I HAD NEAR-CONSTANT NAUSEA FOR ABOUT TWO YEARS AFTERWARDS, MY PERIOD HAS BECOME EXTREMELY HEAVY WITH CLOTTING, PAIN DURING INTERCOURSE, MOOD SWINGS AND IRRITABILITY, SHARP, STABBING PAIN IN MY PELVIC AREA (NOT ONLY DURING OVULATION, BUT BEFORE, DURING AND AFTER), MIGRAINES, WEIGHT GAIN, FACIAL HAIR GROWTH. THE PAIN IS THE WORST I'VE EVER FELT IN MY LIFE. I'VE TRIED MANY DIFFERENT TYPES OF PRESCRIPTION PAIN KILLERS. NONE HAVE WORKED AND NOT ONE HAS EVEN TAKEN THE EDGE OF THE PAIN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227372 ESSURE TUBAL OCCLUSION HHS CONCEPTUS, INC NA
    227373 ESSURE TUBAL OCCLUSION HHS CONCEPTUS, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other