BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3880381 · Received June 13, 2014

    Report

    Report Number
    MW5036654
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 28, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE DEVICE CAUSED ADENOMYOSIS AND GIANT CELL TUMORS. I HAD A D&C, ABLATION AND MOST RECENTLY A HYSTERECTOMY. TRIGGERED AN AUTOIMMUNE REACTION WHICH CAUSED DISCOID ECZEMA, MIGRAINES, DEPRESSION, ANXIETY AND ELEVATED SUGAR LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350056 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention| S