BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3910668 · Received July 2, 2014

    Report

    Report Number
    MW5037005
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    December 15, 2011
    Report Date
    June 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PELVIC PAIN, INCREASE IN ECZEMA, BLOATING,. NEW FOOD ALLERGIES, IBS, FATIGUE. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON 07/03/2014: FORGOT TO ADD DIPS IN BLOOD PRESSURE. NEARLY DAILY HEADACHES. MEMORY TROUBLE. FOGGY MIND. INCREASED BLOOD SUGAR. ABDOMINAL PAIN AND CRAMPS.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON 07/14/2014: GOT A COPY OF MY IMPLANTATION RECORDS TODAY. DATE WAS (B)(6) 2010. DR OFFICE FORGED CONSENT FORM, WHICH I SAW FOR THE FIRST TIME OF PICKING UP COPIES TODAY (B)(6) 2014. HAD I KNOWN ESSURE CONTAINED NICKEL, WHICH I'VE KNOWN I WAS ALLERGIC TO SINCE I WAS A TEEN, I NEVER WOULD HAVE GONE THROUGH WITH THIS AND DEFINITELY WOULDN'T HAVE SIGNED THE FORGED CONSENT FORM I DISCOVERED TODAY. I WAS ASKED TO PICK UP A DOSE OF TORADOL FROM MY PHARMACY TO TAKE BEFORE THE PROCEDURE, BUT A MYSTERIOUS LOT NUMBER FOR THE DRUG IS IN MY FILE. MY DOCTOR LEFT RIGHT AFTER PLACING MY DEVICES AND HIS NURSES HAD TO GET ORDERS FROM HIM OVER THE PHONE WHEN MY BP WENT TO 73/39. I WAS IN THE OFFICE FOR OVER 2 HOURS AFTER THE PROCEDURE WHILE THE NURSES TRIED TO REGULATE MY BP AND NAUSEA. MY FILE ALSO SAYS I WAS GIVEN AN ESSURE CARD, BUT I NEVER RECEIVED ANY SUCH THING.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON (B)(6) 2014: WANT TO ADD THAT PROCEDURE WAS DONE IN DOCTOR OFFICE WITHOUT ANESTHESIA. IT WAS INCREDIBLY PAINFUL AND I PASSED OUT. THE NURSE TOLD ME IT WAS A VASO-VAGAL RESPONSE. I HAD LOW BLOOD PRESSURE AND PULSE AND HAD TO BE GIVEN AN INJECTION TO BRING THEM BACK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386343 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 35.000 YR Hospitalization| O