BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3695397 · Received March 19, 2014

    Report

    Report Number
    MW5035090
    Date Received
    March 19, 2014
    Date of Event
    January 20, 2011
    Report Date
    March 19, 2014
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THREE YEARS AGO I HAD THE ESSURE COILS INSERTED INTO BILATERAL FALLOPIAN TUBES. SINCE THEN I HAVE DEVELOPED SEVERE ABDOMINAL AND LOWER BACK PAIN, MORE ON THE RIGHT POWER SIDE. ABNORMAL BLEEDING AND IRREGULAR PERIODS WITH LARGE BLOOD CLOTS. UNKNOWN SKIN RASHES, IRREGULAR HEART RHYTHM, FLUID RETENTION, DENTAL PROBLEMS, VISUAL PROBLEMS, FATIGUE, FLU LIKE SYMPTOMS, BODY ACHES, FINGER AND TOES GOING NUMB, URINARY INCONTINENCE, SEVERE CONSTIPATION, CHRONIC BACTERIAL VANITIES, ABD. BLOATING, WEIGHT GAIN, "MELASTHMA", MEMORY LOSS, VERTIGO, EXPRESSIVE APHASIA, INABILITY TO PRONOUNCE WORDS, HOH, NAUSEA, SEVERE MOOD CHANGES, ABDOMINAL BEHAVIOR, I HAVE LOST MORE THAN HALF MY HAIR, MIGRAINES, SINUS AND ALLERGIES ENHANCEMENT. I DID NOT HAD THESE SYMPTOMS PRIOR TO THE INSERTION OF THESE COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164636 ESSURE ESSURE HHS CONCEPTUS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening| R| S