BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3983314 · Received August 6, 2014

    Report

    Report Number
    MW5037603
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2014
    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 HAVEN'T STOP BLEEDING SINCE I HAD THE PROCEDURE BACK IN (B)(6), 2014. I THOUGHT THE CRAMPING AND PAIN AFTER THE FIRST 2 WEEKS WAS NORMAL. I GET STABBING PAIN IN MY UTERUS, I STILL BLEEDING , AM BLOATED AND I FEEL REALLY TIRED. I NOTICED THAT I GET ITCHING AND NUMBNESS IN THE BACK OF MY HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459449 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 34.000 YR Other