BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4251159 · Received November 4, 2014

    Report

    Report Number
    MW5039005
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 4, 2014
    Manufacturer
    CONCEPTUS INC
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING THE ESSURE PROCEDURE I HAD SWELLING, MUSCLE WEAKNESS, TINGLING IN FACE, ARMS, LEGS, HIP PAIN, MULTIPLE BURSITIS, FOGGINESS, HEADACHES, DIZZY SPELLS, UNEXPLAINED RASH THAT COMES AND GOES, IRREGULAR PERIODS CAUSING BLOOD CLOTS. I HAVE UNDERGONE MULTIPLE TESTING TO RULE OUT CERTAIN DISEASE THAT WOULD CAUSE MY SYMPTOMS ALL HAVE COME BACK NEGATIVE THE LAST TESTING I HAD WAS FOR NICKEL ALLERGY WHICH CAME BACK POSITIVE BECAUSE OF THIS I WILL HAVE TO HAVE A HYSTERECTOMY TO REMOVE THE COILS. THIS HAS EFFECT ME BY NOT BEING ABLE TO WORK FULL TIME. I AM IN CONSTANT PAIN AND ALWAYS TIRED. INSTEAD OF FEELING LIKE (B)(6) I FEEL LIKE 70. I HOPE SOMETHING IS DONE ABOUT ESSURE SOON TO PREVENT OTHER WOMEN FORM HAVING THE SAME COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706834 ESSURE ESSURE HHS CONCEPTUS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention| S