BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4080809 · Received September 7, 2014

    Report

    Report Number
    MW5038105
    Event Type
    Injury
    Date Received
    September 7, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 7, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD HEAVY MENSTRUAL CYCLES FOR 6 YEARS, CHRONIC ABDOMINAL PAIN, PAINFUL INTERCOURSE, MIGRAINES, BACK PAIN, DEPRESSION. HYSTERECTOMY BECAUSE COILS MIGRATED TO UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547309 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Disability