BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4903503 · Received July 9, 2015

    Report

    Report Number
    MW5043855
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    July 2, 2013
    Report Date
    June 8, 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). MY DOCTOR PLACED ONE COIL IN. ONE OF MY TUBES WAS BLOCKED NATURALLY. I HAVE SEVERE BLOATING, FATIGUE, SEVERE PAIN DURING SEXUAL INTERCOURSE AND PAIN WHILE ON THE MENSTRUAL CYCLE. SEVERE BACK PAIN. AND SEVERE MOOD SWINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447008 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 29.000 YR Other