BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913308 · Received June 30, 2014

    Report

    Report Number
    MW5037042
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 28, 2014
    Manufacturer
    BAYER/CONCEPTS INCORPORATED
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REC'D THE ESSURE IN 2011 AND HAD TO HAVE A HYSTERECTOMY IN (B)(6) 2013. I HAD DEVELOPED EDEMATOUS, WHICH I NEVER HAD MAJOR STOMACH AND BACK PAIN. EVERY SINGLE DAY BACK PAIN WITH INTERCOURSE, MY LIFE WAS TERRIBLE. I BEG DOCTORS TO HELP ME UNTIL I FINALLY FOUND ONE AND HAD TO HAVE THEN REMOVED, THAN GOD SHE DID BECAUSE I HAD VERY BAD EDEMATOUS I LOST SO MUCH WEIGHT COULDN'T EAT OR EVEN SLEEP COMFORTABLE FATIGUE I AM NOT E-FREE BUT SUFFERING FROM NOT FEELING LIKE A NORMAL WOMAN ANYMORE AND DEPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379142 ESSURE NONE HHS BAYER/CONCEPTS INCORPORATED REF # ESS305 789034

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| O| R