BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3872192 · Received June 9, 2014

    Report

    Report Number
    MW5036566
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    October 25, 2011
    Report Date
    June 6, 2014
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ESSURE PROCEDURE (B)(6) 2011 AND HAVE HAD PAIN IN MY SIDES, NAUSEA, CRAMPING, PELVIC PAIN, NIGHT SWEATS, LONG MENSTRUAL CYCLES, METALLIC TASTE IN MOUTH, HEARTBURN, DIZZINESS, AND WEIGHT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334242 ESSURE ESSURE HHS CONCEPTUS 869762 ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR