BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3875260 · Received June 16, 2014

    Report

    Report Number
    MW5036608
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    October 6, 2006
    Report Date
    August 25, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PELVIC PAIN, ACNE, JOINT AND MUSCLE PAIN, METALLIC TASTE IN MOUTH, PAINFUL INTERCOURSE, HEAVY PERIODS WITH CLOTS ( UTERINE ABLATION WAS DONE), PAINFUL PERIODS,FIBROMYALGIA, PLANTAR FASCIITIS REQUIRING 2 SURGERIES, HIVES, RASHES, VAGINAL ITCHING( NO DISCHARGE), BACK PAIN, FEVERS, WEIGHT DRAIN, FATIGUE, NAUSEA, DIZZINESS ,BLOATING,SWELLING IN EXTREMITIES , CHEST PALPITATIONS, DEPRESSION, ANXIETY, TREMORS, HAIR THINNING, MEMORY LOSS, LOW VITAMIN D, MOUTH SORES, INSOMNIA , HEART BURN, PANIC ATTACKS,MOOD SWINGS, CYSTS, BREAST PAIN AND CYSTS, NECK AND SPINE PAIN. C-REACTIVE PROTEIN ELEVATED 9-80. (B)(4).

    Description of Event or Problem · 1

    (B)(4). HYSTERECTOMY LAVH/ BS LEFT OOPHORECTOMY (B)(6) 2014. ADENOMYOSIS LEIOMYOMA LEFT FALLOPIAN TUBE SMALL FOCUS OF HEMORRHAGE AND ACUTE INFLAMMATION PARATUBAL CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352684 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 0.000 YR Hospitalization| O| S