BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3032708 · Received April 2, 2013

    Report

    Report Number
    MW5029577
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    December 5, 2007
    Report Date
    April 2, 2013
    Manufacturer
    CONCEPTUS INC.
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED ON 2 SEPARATE DATES. (RIGHT SIDE ON (B)(6) 2007 AND THE LEFT SIDE ON (B)(6) 2008). HER FIRST COMPLAINT IS THE DIFFICULT IMPLANTATION PROCEDURE SHE HAD TO ENDURE. THE FIRST X-RAY IMAGES SHOWED THAT ONLY 1 OF HER FALLOPIAN TUBES WAS BLOCKED. ON (B)(6) 2008, THE X-RAY IMAGES SHOWED THAT BOTH FALLOPIAN TUBES WERE THEN BLOCKED. SECONDLY, SHE HAS HAD A MYRIAD OF PROBLEMS SINCE THE IMPLANTATION NAMELY, HEAVY BLEEDING, CRAMPING, SHARP STABBING PAIN, BACK PAIN, JOINT PAIN, FATIGUE, DIZZINESS, WEIGHT GAIN, SWELLING OF FEET AND LEGS, IRREGULAR HEAVY PERIODS, VITAMIN D DEFICIENCY, FORGETFULNESS, CONSTANT SPOTTING, DISCHARGE, BLADDER ISSUES AND HEAVY BLOOD CLOTS. SHE WAS EVENTUALLY DIAGNOSED WITH AN AUTOIMMUNE DISORDER (PSORIASIS). SHE'S PRESENTLY SERIOUSLY CONSIDERING EXPLANTATION. HER MESSAGE TO CONCEPTUS INC. SHE'S DISAPPOINTED THAT CONSUMERS WERE NOT INFORMED THAT THEIR RIGHTS TO SUE THE MANUFACTURER HAD BEEN WAIVED. SHE'S DISAPPOINTED AT THE WAY THE OPERATION WAS PERFORMED. SHE'S DISAPPOINTED AT ALL THE DIFFICULTIES SHE'LL HAVE TO GO THROUGH JUST TO HAVE THE DEVICE EXPLANTED. SHE THEREFORE, WANTS TO BE COMPENSATED FOR THE EXPENSES SHE HAS AND WOULD INCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133803 ESSURE INTRAUTERINE DEVICE HHS CONCEPTUS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other