BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4810368 · Received May 27, 2015

    Report

    Report Number
    MW5042864
    Event Type
    Injury
    Date Received
    May 27, 2015
    Report Date
    May 27, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE COIL INSERTED AND HAD A TERRIBLE ALLERGIC REACTION. ALL THE MUSCLES IN MY BODY STIFFENED AND I COULD HARDLY WALK, ESPECIALLY AFTER SITTING STILL FOR A WILE (EXAMPLE: AFTER DRIVING OR WORKING AT MY DESK). I COMPLAINED TO MY DOCTORS AND THEY ALL INSISTED THIS WAS NOT THE CAUSE OF MY TROUBLE. I WAS DIAGNOSED WITH FIBROMYALGIA BECAUSE THEY COULD NOT FIGURE OUT THE CAUSE OF PAIN. I SWITCHED DOCTORS (CLINICS). THE NEW DOCTOR SENT ME TO A GYNECOLOGIST AND SHE DID A HYSTERECTOMY. THE PAIN IS GONE. A TEST WAS NEVER DONE TO SEE IF I HAD AN ALLERGIC REACTION TO NICKEL OR WHAT THE DEVICE WAS MADE FROM. IT WAS THE WORST 2 YEARS EVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341342 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR