BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE PROCEDURE

    MDR report key: 3040094 · Received April 1, 2013

    Report

    Report Number
    MW5029625
    Event Type
    Injury
    Date Received
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CONCEPTUS INC
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD THE ESSURE PROCEDURE SINCE 2005. I HAVE HAD SEVERAL ISSUES WITH THIS PROCEDURE: HEADACHES, NAUSEA, CRAMPING, HEAVY BLEEDING, CLOTTING, BLOODY STOOL, DEPRESSION, WEIGHT GAIN AND SEVERAL OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132753 ESSURE PROCEDURE ESSURE HHS CONCEPTUS INC 12271872

    Patients

    Seq Age Sex Outcome Treatment
    1 Other