BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3756145 · Received April 17, 2014

    Report

    Report Number
    MW5035641
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    February 14, 2013
    Report Date
    April 9, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED HAVING VERY BAD CRAMPS, AND STARTED TO PUT WEIGHT BACK ON THAT I WAS LOSING SINCE THE BIRTH OF MY DAUGHTER 4 MONTHS BEFORE, ALSO STARTED TO LOSE MILK SUPPLY.. A FEW MONTHS AFTER THAT MY HAIR STARTED TO FALL OUT.. OUT OF NO WHERE I WOULD GET VERY PAINFUL STABBING FEELING.. IT ALSO 2 MONTHS AFTER HAVING ESSURE PLACED, MY MS PAIN GOT WORSE WITH NO CHANGE IN BRAIN OR SPINE ( USE OF MRI TO CHECK).. ALSO (B)(6) 2013 I FOUND OUT I WAS PREGNANT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235707 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Other