BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3881368 · Received June 18, 2014

    Report

    Report Number
    MW5036664
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    August 1, 2013
    Report Date
    June 4, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    EXTREME SCRATCHING ALL OVER BODY, MAINLY HEAD, EXTREMELY VIVID NIGHTMARES, RASHES, OVARIAN CYSTS, PAIN IN HANDS, AND LEGS, SWOLLEN ABDOMEN, FREQUENT URINATION, NIGHT SWEATS, HOT FLASHES, BRUISING, MIGRAINES, FIBROIDS IN UTERUS, CONSTANT PAIN IN RIGHT ABDOMEN, CONSTANT DISCOMFORT IN ABDOMEN, AND LEGS, SHOOTING PAIN IN LEGS, HEART RACING, MOOD SWINGS, FOUL SMELLING DISCHARGE, WEIGHT GAIN, SWELLING IN LEGS AND ANKLES, ACNE, PAIN DURING INTERCOURSE, ANXIETY, BACK PAIN, PAIN IN RIGHT SIDE UNDER RIBS, PUCKERING ON BREASTS, PAIN IN CHEST, AND ARMPITS, SMALL CYSTS IN ARMPITS, SHOOTING PAIN FROM CHEST TO ARMPITS, HEAVY PERIODS, BLOOD CLOTS, EXTREME CRAMPING CONSTANTLY, DIZZINESS, FATIGUE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357780 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 29.000 YR Hospitalization| L| O| S