BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5030685

    MDR report key: 3193595 · Received June 21, 2013

    Report

    Report Number
    MW5030685
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 21, 2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE A PRODUCT OF CONCEPTUS HAS CAUSED ME NOTHING BUT PAIN, INFLAMMATION, AND SWELLING, AND I AM NOW HAVING TO HAVE SURGERY TO REMOVE THE COILS AND POSSIBLY SECTIONS OF MY UTERUS AS WELL. DOSE OR AMOUNT: COILS. ROUTE: INTRACERVICAL. DIAGNOSIS OR REASON FOR USE: TUBAL LIGATION.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other