BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5153581 · Received October 15, 2015

    Report

    Report Number
    MW5056996
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    March 10, 2014
    Report Date
    October 13, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). ONSET OF EXCESSIVE BLEEDING CRAMPING AND HEAVY CLOTS EXPERIENCED WITHIN 8 WEEKS OF IMPLANT DATE ((B)(6) 2013). WAS PLACED ON MINASTRIN 24 FE TO REGULATE BLEEDING. SINCE THE IMPLANT OF THE DEVICES I HAVE EXPERIENCED THE FOLLOWING SIDE EFFECTS: EXCESSIVE AND HEAVY MENSES, CRAMPING, SEVERE BLOATING, NAUSEA, EXTREMELY PAINFUL SEXUAL INTERCOURSE, MUSCLE SPASMS AND TWITCHES, MUSCLE CRAMPS, MIGRAINES, BLURRED VISION, DECREASE IN VISION ACUTENESS, FLOATERS IN VISION, ANXIETY, SEVERE CONSTANT HEADACHE AND NECK PAIN, JOINT PAIN MORE SO IN HIPS, BACK, NECK, JAW, ITCHY SKIN, RANDOM PATCHES OF DERMATITIS (UNKNOWN CAUSE), HAIR LOSS, RINGING IN EARS, SLEEPLESSNESS AND INSOMNIA, STABBING PAINS IN UTERUS, "KICKING" SENSATION IN ABDOMEN, SEVERE MOOD SWINGS, OVERALL MALAISE, INCREASING TIREDNESS, VAGINITIS, STABBING PAIN AROUND OPENING OF VAGINA, SEVERE PELVIC PAIN, GI DISCOMFORT AND ISSUES, FOOD SENSITIVITY, UNCONTROLLABLE SUGAR CRAVINGS, NUMBNESS AND STIFFNESS OF HANDS, TINGLING IN HANDS, SUPERFICIAL BLOOD CLOTTING IN LEGS, EASY BRUISING, WEAKENED IMMUNE SYSTEM, BURNING AND ITCHING INSIDE OF UTERUS, SEVERE JAW JOINT PAIN, SEVERE PMS SYMPTOMS, HEART PALPITATIONS AND RAPID HEART BEAT, SHORT OF BREATH FREQUENTLY.

    Description of Event or Problem · 1

    (B)(4). LEFT OUT SYMPTOMS OF SEVERE MEMORY FOG, FREQUENT URINATION, MENTAL CONFUSION AND FORGETFULNESS, STABBING PAINS SIMILAR TO GALL BLADDER ATTACK, HAD GALLBLADDER REMOVED A YEAR PRIOR TO ESSURE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683795 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR Hospitalization