BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913623 · Received June 30, 2014

    Report

    Report Number
    MW5037046
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    December 4, 2013
    Report Date
    June 29, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ESSURE PERMANENT BIRTH CONTROL PLACED (B)(6) 2013. HAD HSG RADIOLOGICAL TEST COMPLETED (B)(6) 2014 TO TEST FOR BLOCKAGE OF FALLOPIAN TUBES. DURING HSG DYE FLUSHING, THE LEFT ESSURE COIL WAS FLUSHED COMPLETELY THROUGH MY FALLOPIAN TUBE AND INTO MY PERINEAL CAVITY. DOCTOR HAS SUGGESTED SURGERY TO HAVE MISPLACED COIL FOUND AND REMOVED. ALSO DURING SURGERY, I WOULD REQUIRE MY LEFT TUBE TO BE TIES TO PREVENT PREGNANCIES. DO NOT HAVE FINANCIAL ABILITY TO HAVE SURGERY AT CURRENT TIME. ALSO HAVE EXPERIENCED JOINT PAIN AND 30 LB UNEXPLAINED WEIGHT GAIN. SEVERE DEPRESSION RELATED TO COMPLICATIONS RELATED TO ESSURE DEVICE DISLODGEMENT AND PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379107 ESSURE NONE HHS BAYER WASN'T GIVEN TO ME. WASN'T GIVEN TO ME.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other