BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3874190 · Received June 10, 2014

    Report

    Report Number
    MW5036597
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    June 9, 2014
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GOT THE ESSURE IMPLANTED LAST (B)(6) PER MY DOCTOR'S REQUEST INSTEAD OF LITIGATION. I LET HIM KNOW I'M ALLERGIC TO METAL AND HE SAID IT'D BE FINE. BY (B)(6), I'D BEEN TO THE HOSPITAL 3 TIMES FOR CHRONIC HIVES. I'D SEEN MY DOCTOR THAT WEEK. MY BLOOD PRESSURE WAS 80/40, AND I ENDED UP IN THE EMERGENCY ROOM 2 STATES FROM HOME. MY HEART CONTINUED TO RACE, AND AS I STABILIZED AFTER THEY CHECKED MY EKG, THEY WOULDN'T LET ME GO FOR HOURS BECAUSE IT WOULDN'T CALM DOWN EVEN WHEN I WAS ASLEEP. IN THE LAST YEAR I'VE HAD CHRONIC HIVES AT LEAST 130 DAYS OF THE LAST YEAR. I HAVE PAIN ALL OVER. MY HANDS AND FEET ARE NUMB. I'VE GAINED 80 POUNDS. AND I'VE BEEN CALLED CRAZY BY MANY DOCTORS; PRETTY SURE THEY STILL THINK I'M CRAZY. WHEN I LEFT MY NETWORK OF DOCTORS FRIDAY THE ONE I GOT BY CHANCE TESTED ALL THE NORMAL THINGS THAT WOULD CAUSE ALLERGIC REACTION IN LABS. THE ONLY THING HE COULD BRING IT BACK TO IS THE ESSURE. I SHOULD HAVE THOUGHT OF IT, IT WAS THE SAME TIMELINE. I NEVER EXPECTED TO FEEL SO TERRIBLE A YEAR LATER. I HAVE NEVER, EVER FELT THIS BAD IN MY ENTIRE LIFE. I'M PRETTY SURE I NOW HAVE TO SPEND TIME FIGHTING TO GET IT REMOVED. THE DOCTOR WHO DID IT IS NO LONGER AROUND, AND IT'S NOT COMMON IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337534 ESSURE ESSURE HHS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other