BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3781546 · Received April 30, 2014

    Report

    Report Number
    MW5035832
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    October 14, 2013
    Report Date
    April 26, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALLERGIES, PAIN DURING RELATION, FATIGUE, BRAIN FOG, BLEEDING, INFLAMMATION, LOWER ABDOMEN PAIN, LOWER BACK PAIN, MIGRAINE, ETC. (B)(4).

    Description of Event or Problem · 1

    (B)(4). WHAT THE FDA IS GOING TO DO ABOUT ESSURE? THOUSAND YOUNG WOMAN ARE ENDING LIKE ME, HAVING HYSTERECTOMY BECAUSE ESSURE.!!!!!!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260007 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 35.000 YR Hospitalization| O| S