BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3802978 · Received May 5, 2014

    Report

    Report Number
    MW5035953
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    December 16, 2010
    Report Date
    May 4, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE IMPLANTED ON (B)(6) 2010. SINCE THE PROCEDURE DATE, I HAVE HAD TREMENDOUS PAIN IN THE COIL PLACEMENT AREAS WHEN GOING FROM A SITTING TO STANDING POSITION. VERY PAINFUL, FEELS LIKE SHARP/STABBING AND LITERALLY MAKES ME DOUBLE OVER IN PAIN. IT HAPPENS DAILY. INTENSE BLOATING, HEADACHE, VISION PROBLEMS THAT COME AND GO (SEEING FLOATING BLACK SPECKS), MEMORY LOSS, MIXING WORDS WHEN I SPEAK, ITCHING LIKE I HAVE A RASH BUT I DON'T, NUMBNESS/LOSS OF FEELING IN LEGS, SEVERE PAIN AT TIME OF OVULATION AND INTENSE PAIN PRIOR TO MENSTRUAL CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267887 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Disability