BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3365556 · Received September 18, 2013

    Report

    Report Number
    MW5031942
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 22, 2012
    Report Date
    September 17, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ESSURE PLACED ONE YEAR AGO. PAINFUL CYCLES SO BAD CAN'T WALK FOR 2 DAYS TOOK PAIN MEDS PRESCRIBED AND OTC NOTHING HELPED. SEEN NEW MEDICAL DOCTOR WHO DID INTERNAL ULTRASOUND, SHE FOUND OUT ONE COIL HAS COME HALFWAY OUT AND ONE END OF IT IS EMBEDDED IN UTERUS. HAVE TO HAVE SURGERY TO SEE IF IT CAN BE REMOVED BY DOING A TUBAL TO HAVE ACCESS ON BOTH SIDES OF THE COIL TO MAYBE GET IT OUT. IF NOT WILL HAVE TO HAVE A HYSTERECTOMY RIGHT THEN. JUST BECAUSE MY OLD DOCTOR SAID ITS 100 PERCENT SAFE AND PAIN FREE. SHE CAUSED ME SO MUCH PAIN PUTTING IT IN AND THEN SAID "OH I GUESS I USED THE WRONG SIZE OF ROD TO PUT IN THE COILS". LET'S TAKE THOSE OUT AND START OVER AGAIN. 'SECOND TIME AFTER SHE WAS DONE I ALMOST PASSED OUT FROM PAIN AND NAUSEA THEY HAD ME LAY BACK DOWN AND WHEN I HAD BEEN THERE 30 MINUTES THEY SAID " HONEY YOU HAVE TO LEAVE NOW ITS TIME TO CLOSE THE OFFICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470732 ESSURE ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R| S