BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2143877 · Received June 23, 2011

    Report

    Report Number
    MW5021133
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CONCEPTUS INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE OBTAINING THE ESSURE DEVICE IN 2007. I HAD MY F/U TEST DONE TO DETERMINE THAT BOTH TUBES WERE FULLY BLOCKED. I HAVE HAD DEBILITATING BLEEDING DURING MY MENSTRUAL CYCLES AND EXCESSIVE PAIN IN MY ABDOMEN. DATES OF USE: (B)(6) 2007 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE ESSURE HHS CONCEPTUS INC. ESS305 626207

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention| S