BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3881357 · Received June 18, 2014

    Report

    Report Number
    MW5036663
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 3, 2008
    Report Date
    June 2, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CHRONIC PELVIC PAIN AND BURNING, CRAMPING SENSATIONS. SENSITIVITY TO METALS. SENSITIVITY TO SUPPLEMENTS, MEDICATIONS, HYGIENE PRODUCTS AND FOODS WHICH I COULD PREVIOUSLY TOLERATE. FREQUENT SYMPTOMS OF UTI, BUT OFTEN NO INFECTION DIAGNOSED. SHARP STABBING PAINS IN PELVIC AREA, ON RIGHT AND LEFT SIDES, WORSE WHEN SITTING, WORST WHEN DRIVING. ANXIETY AND DEPRESSION. REDNESS AND INFLAMMATION IN PELVIC AREA. CHRONIC ABDOMINAL BLOATING, RESEMBLING PREGNANCY. SHOOTING PAINS DOWN LEGS, CHRONIC BURNING SENSATION IN SOLES OF FEET. OVARIAN CYST. PAINS IN VULVAR AREA. CYSTS IN VULVAR AREA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357031 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 55.000 YR Other HYDROCHLOROTHIAZIDE