BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3910684 · Received July 2, 2014

    Report

    Report Number
    MW5037006
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 29, 2014
    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

    TODAY I HAVE BEEN IN SEVERE PAIN BUT IT WOULDN'T LET ME PICK THE ACTUAL DAY THIS STARTED; THIS STARTED RIGHT AFTER I HAD ESSURE IMPLANTED INTO MY FALLOPIAN TUBES (B)(6) 2012; I WAS IN SEVERE STOMACH AND PELVIC PAIN AND A FEW DAYS LATER, I HAD A THICK AMOUNT OF SCAR TISSUE OR SOMETHING FALL OUT. I TOOK IT TO MY DOCTOR AND THEY SAID IT WASN'T A MISCARRIAGE, DUH I ALREADY KNEW THAT IT HAD TO BE SOMETHING FROM MY SURGERY. I HAVE DEVELOPED IBS FROM THIS DEVICE, HOT FLASHES AND SO MUCH STOMACH PAIN; I CAN'T TAKE IT SOMETIMES AND HAVE BEEN PUT INTO THE HOSPITAL AND I HAVE NO INJURY, CONSTANT ITCHING MY LEGS AND BODY, SEVERE HEADACHES AND LIGHTHEADEDNESS. THIS DEVICE NEEDS TO BE OFF THE MARKET, THE SIDE EFFECTS ARE BAD. I WILL COME BACK AND ADD ON MY LAB REPORTS AND HOSPITAL REPORTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386898 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 24.000 YR Hospitalization| O ESSURE