BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4479515 · Received January 28, 2015

    Report

    Report Number
    MW5040556
    Event Type
    Injury
    Date Received
    January 28, 2015
    Date of Event
    January 6, 2014
    Report Date
    January 28, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GOT ESSURE (B)(6) 2010. DID THE HCG TEST AND ALL WAS BLOCKED AND WHERE IT WAS SUPPOSED TO BE. AFTER ABOUT 6 MO., I HAVE HAD HIGH BLOOD PRESSURE, IRREGULAR PERIODS, PAINFUL INTERCOURSE, HIP AND JOINT PAIN, INSOMNIA, WEIGHT GAIN, MUSCLE SPASM, DRY EYES/SKIN/HAIR, CRAMPING, SHARP STABBING PELVIC PAIN, HOT FLASHES, PCOS EXCESSIVE BLEEDING IN PERIODS , LONG MENSTRUAL CYCLES, SPOTTING AFTER INTERCOURSE, ITCHING OF VAGINAL ENTRANCE AND LIPS, BREAST TENDERNESS, ABDOMINAL FLUTTERING, BACK HIP/JOINT PELVIC PAIN, ALL OVER BODY ACHES, FATIGUE, METAL TASTE IN MOUTH, HEARTBURN, HEADACHES AND MIGRAINES, DIZZINESS, FAINTING, TINGLING, AND NUMBNESS IN ARMS/HANDS/LEGS/FEET, FORGETFULNESS, RINGING IN EARS, SKIN FEELS LIKE ITS BURNING OR TINGLING, TREMORS/SHAKINESS AND EASILY UNEXPLAINED BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63308 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other