BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4971293 · Received August 5, 2015

    Report

    Report Number
    MW5045061
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    August 1, 2009
    Report Date
    July 1, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). I HAD MINE IMPLANTED IN ABOUT (B)(6) 2009. I HAD NO PROBLEMS AND NO REAL PAIN DURING IMPLANT. ABOUT ONE MONTH LATER, I STARTED HAVING SEVERE AND CONSTANT PELVIC PAIN. MY SYMPTOMS PROGRESSED AND I BEGAN HAVING SEVERE HEADACHES 24 HOURS A DAY. I ALSO HAD BACK PAIN. IT GOT TO THE POINT, WHERE I DEMANDED THEY BE REMOVED EVEN AFTER BEING TOLD IT WOULD LIKELY REQUIRE A HYSTERECTOMY. I HAD A SIX HOUR SURGERY, AND I LOST ONE TUBE. I HAVE BEEN SYMPTOM FREE SINCE REMOVAL. MY DOCTOR SENT ME TO SEVERAL OTHER DOCTORS BEFORE REMOVAL TO MAKE SURE THAT I DID NOT HAVE ANY OTHER ISSUES. NO OTHER DOCTOR FOUND ANYTHING WRONG WITH ME. I WAS VERY HEALTHY WITH NO OTHER ILLNESSES AT THE TIME OF IMPLANT. I HAD THE IMPLANT ABOUT 3 MONTHS AFTER MY LAST CHILD WAS BORN. I HAVE NEVER BEEN DIAGNOSED WITH A NICKLE ALLERGY. I HAVE SENSITIVITY TO SOME EARRINGS, BUT NOBODY EVER SUGGESTED A NICKLE TEST. I AM ALLERGIC TO NUMEROUS PRESCRIPTION MEDICATIONS INCLUDING KELFEX, SULFA, CODEINE, PENICILLIN, AND I AM ALSO ALLERGIC TO CERVIDIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512330 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 41.000 YR Hospitalization| O| R