BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5123986 · Received September 28, 2015

    Report

    Report Number
    MW5056765
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    January 6, 2014
    Report Date
    September 28, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROBLEMS AND SYMPTOMS I'VE HAD AND/OR BEEN TESTED/TREATED FOR SINCE HAVING THE ESSURE PROCEDURE COMPLETED IN (B)(6) 2014. CRAMPING, SHARP/STABBING PELVIC PAIN, OVARIAN CYSTS, DISCHARGE (ODOR/NO ODOR), EXCESSIVE BLEEDING DURING PERIOD (MENORRHAGIA), NIGHT SWEATS, LOSS OF LIBIDO, HOT FLASHES PAINFUL PERIODS (DYSMENORRHEA), PAINFUL INTERCOURSE (DYSPAREUNIA). URGENT/FREQUENT URINATION, UTI (URINARY TRACT INFECTION), BLADDER INFECTION, ITCHING, BURNING, STINGING, STABBING OF VAGINAL ENTRANCE (VULVODYNIA) BREAST PAIN/TENDERNESS, ABDOMINAL SPASMS/TWITCHING/FLUTTERING PAIN IN BACK, JOINTS, CHEST,LEGS, BREAST, NECK, SPINE, HIPS CHRONIC PELVIC PAIN, ALL OVER BODY ACHES/PAIN, NAUSEA, VOMITING, GAS, CONSTIPATION, DIARRHEA, SEVERE BLOATING. METALLIC TASTE IN MOUTH, HEARTBURN, BOWEL ISSUES, NEUROLOGICAL, MENTAL HEALTH, HEADACHES OR MIGRAINES, DIZZINESS TINGLING SENSATIONS, NUMBNESS, BRAIN SHOCKS, NERVE PAIN, BRAIN FOG - CLOUDINESS, FORGETFULNESS, ANXIETY/PANIC ATTACKS MOOD SWINGS, SEIZURES DEPRESSION (SADNESS/SUICIDAL THOUGHTS) RINGING IN EARS (PULSATILE TINNITUS), BLACK OUT SPELLS/FAINTING DIMINISHED BRAIN FUNCTION (BRAIN FOG, CONFUSION, CLOUDINESS, FORGETFULNESS, SHORT TERM MEMORY LOSS), NUMBNESS IN THIGH (MERALGIA PARESTHETICA), NUMBNESS/TINGLING IN EXTREMITIES (HANDS/FEET), SENSATION OF BURNING, STINGING, TICKLING OR PRICKLING OF SKIN (PARESTHESIA), NERVE PAIN, TREMORS/SHAKINESS, DIZZINESS, UNEXPLAINED/EASILY BRUISING, RHEUMATOID ARTHRITIS INFLAMMATION, HEIGHTENED ALLERGIES/ALLERGIC REACTIONS, HIVES, RASHES CYSTS, BOILS, ACNE SKIN IRRITATION/ITCHING, SWELLING OF LEGS OR FEET HAIR LOSS OR CHANGES , HARD TO MANAGE THYROID DISEASE (HYPOTHYROID) DEGENERATIVE BONE DISEASE, GALLBLADDER ISSUES (REMOVAL), SWELLING/NUMBNESS IN JAWS/LIPS, SWELLING OF LEGS/FEET, MUSCLE SPASMS, VISION PROBLEMS (FLOATERS, BLURRED VISION, DECREASED VISION), EXCESSIVE SWEATING DRY SKIN/HAIR/EYES, SEVERE BLOATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640174 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability