BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPTUS INC. USA

    MDR report key: 2172207 · Received July 18, 2011

    Report

    Report Number
    MW5021421
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    December 23, 2008
    Report Date
    July 18, 2011
    Manufacturer
    CONCEPTUS INC., USA
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE IMPLANTS DONE IN (B)(6) 2008. WHAT WAS SUPPOSED TO BE A 12-15 MIN PROCEDURE TOOK OVER 45 MIN DUE TO THE DOCTOR HAVING DIFFICULTIES PLACING THE IMPLANTS INTO MY FALLOPIAN TUBES. THE DOCTOR FIRST TRIED TO DO THE PROCEDURE IN (B)(6) 2008 WITHOUT SUCCESS AND I HAD TO GO BACK AGAIN IN (B)(6) 2008. I HAVE BEEN SICK FOR OVER 2 YRS NOW AND DIDN'T KNOW WHY. I WAS HOSPITALIZED 4 TIMES IN A 2 WEEK PERIOD THIS (B)(6) 2011 WITH SEVERE ABDOMINAL PAIN, CHEST PAIN, FAINTING, HEADACHES, MUSCLE ACHES, DIARRHEA, ETC. THE ER DOCTOR HAD A CT SCAN DONE AND IT SHOWED THAT I HAVE AN ESSURE COIL LODGED IN MY RECTAL WALL! I HAVE AN APPOINTMENT WITH A COLORECTAL SURGEON TODAY TO DISCUSS SURGERY TO REMOVE THE LODGED COIL AND ANOTHER APPOINTMENT WITH AN OB/GYN TO DISCUSS REMOVAL OF THE COIL IN MY FALLOPIAN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCEPTUS INC. USA ESSURE IMPLANTS HHS CONCEPTUS INC., USA 627759 LEFT TUBE
    2 CONCEPTUS INC. USA ESSURE IMPLANTS HHS CONCEPTUS INC., USA 627436 RIGHT TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization