BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 2113369 · Received May 27, 2011

    Report

    Report Number
    MW5020830
    Event Type
    Injury
    Date Received
    May 27, 2011
    Date of Event
    April 1, 2010
    Report Date
    May 27, 2011
    Manufacturer
    CONCEPTUS INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAD ESSURE IMPLANTED IN FALLOPIAN TUBES IN 2007. TOOK THE 3 MONTH VERIFICATION TEST. CONFIRMED 100% BLOCKED. HAVE HAD HEAVY BLEEDING, PAINFUL CRAMPS SINCE THEN. BECAME PREGNANT (B)(6) 2010. HAD A BABY (B)(6) 2010. I HAVE COME ACROSS MANY WOMEN THROUGH INTERNET WITH SAME PROBLEMS. SPOKE TO ESSURE TO REPORT PROBLEMS PREGNANCY AND BIRTH. THEY SAY SOME ONE WILL CALL BACK BUT NUMEROUS CALLS SINCE LAST YR AND STILL NO CALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other