BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3884464 · Received June 19, 2014

    Report

    Report Number
    MW5036674
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 10, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON (B)(6) 2014: SINCE POSTING THIS, I HAVE NOW HAD TO HAVE A HYSTERECTOMY. I HAD THIS SURGERY ON (B)(6) 2014. THEY REMOVED MY UTERUS AND TUBES, BUT WERE ABLE TO LEAVE MY OVARIES. BEING (B)(6), YOU CAN SEE WHY I AM UPSET THAT I HAD TO HAVE THIS DONE AT SUCH A YOUNG AGE. I AM HAVING TO MISS WEEKS OF WORK, AS WELL AS NOT BEING ABLE TO PICK UP MY KIDS FOR 6 WEEKS BECAUSE OF MY WEIGHT RESTRICTIONS.

    Description of Event or Problem · 1

    IT STARTED WHEN I HAD IT INSERTED IN (B)(6), WITH AN EXCRUCIATING INSERTION OF THE ESSURE. EVEN MY DOCTOR SAID IT WAS UNCOMMON THAT IT HURT SO BAD. THE CRAMPING AND SHARP PAIN CONTINUED THROUGH THE WEEKS, GETTING WORSE AND WORSE. MY HSG TEST CONFIRMED THAT I WAS NOT IN FACT STERILE, NOR WERE THE IMPLANTS IN PLACE. AT THIS TIME THROUGH NOW, I HAVE LOST AN ABUNDANCE OF HAIR, HAVE ITCHINESS ALL OVER MY BODY, MAINLY MY FACE, AND AM IN CONSTANT PAIN. THE PAIN LEVELS COME AND GO, TO WHERE SOME DAYS IT IS MILD CRAMPING, TO PAIN THAT KEEPS ME IN BED HALF THE DAY. I HAVE BEEN SCHEDULED FOR A HYSTERECTOMY WITH MY NEW DOCTOR FOR TWO WEEKS FROM NOW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361177 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32.000 YR Hospitalization| L| O| S I HAVE BEEN USING NO OTHER MEDICATION WITH THIS,.