BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4899591 · Received July 8, 2015

    Report

    Report Number
    MW5043729
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    February 14, 2011
    Report Date
    May 26, 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). AFTER I GOTTEN THE ESSURE PUT IN I HAVE HAD BAD BLEEDING ALL THE TIME. I FOUND OUT AFTER HAVING ESSURE PUT IN THAT I HAVE IBS AND INTERSTITIAL CYSTITIS. I AM SO SWOLLEN IN THE BELLY . I AM CRAMPING ALL THE TIME. I CAN'T SLEEP BECAUSE OF THE PAIN I AM DEALING WITH. I AM HAVING A LOT OF MEMORY LOSS, MORE EACH DAY. I GET LIGHT HEADEDNESS. I AM TWITCHING SO BAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442387 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 0.000 YR Other I TAKE NO OTHER MEDICATIONS AT THIS TIME.