BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4560242 · Received March 2, 2015

    Report

    Report Number
    MW5040983
    Event Type
    Injury
    Date Received
    March 2, 2015
    Date of Event
    February 1, 2013
    Report Date
    January 5, 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). HIP PAIN AND SWOLLEN LEFT HIP, LEG CRAMPS AND ANKLE AND FEET SWELLING, EXTREME CRAMPS AND PELVIC PAIN, SHARP AND STABBING PELVIC PAIN, LOWER BACK PAIN, HEADACHES, DEPRESSION, STRESS AND ANXIETY, MOOD SWINGS, EXTREME HOT FLASHES, I FEEL LIKE I';M GOING THROUGH MENOPAUSE - BEEN TESTED FOR IT BUT DR SAID MY TESTS CAME OUT FINE, DRY VAGINAL, PAINFUL DURING SEX, VAGINAL ODOR, BELLY BUTTON LEAKAGE, PAINFUL PERIODS, NIPPLES ARE VERY SORE AND SENSITIVE, HEARTBURN, FORGETFULNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144508 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 39.000 YR ESSURE