BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5391161 · Received January 26, 2016

    Report

    Report Number
    MW5059613
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    June 21, 2014
    Report Date
    January 25, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). AFTER THIS DEVICE MY LIFE CHANGED COMPLETELY, PELVIC PAIN, KNEE PAIN, LEG PAIN, HEADACHES, SHOULDER PAIN, NUMBNESS OF RIGHT ARM AND LEG, BACK PAIN, PAINFUL PERIODS, MOOD SWING, BRAIN FOG, FATIGUE ALL THE TIME, VAGINAL INFECTIONS, PND PAINFUL INTERCOURSE. DUE TO THIS SYMPTOMS I ALMOST LOST MY MARRIAGE AND I BEEN VERY MEAN WITH MY KIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48774 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31.000 YR Hospitalization| L| O| S