BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3456715 · Received November 7, 2013

    Report

    Report Number
    MW5032599
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    December 1, 2012
    Report Date
    June 7, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE IMPLANTED (B)(6) 2010. FOR THE PAST 4 MONTHS HAVE FOLLOWING SYMPTOMS: CONSTANT CRAMPING ON PELVIC RIGHT SIDE, CONSTANT BREAST TENDERNESS, FATIGUE, MENTAL FOG, TINGLING IN LEFT ARM. ALSO AM STARTING MENOPAUSE AT AGE IF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576928 ESSURE HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 38.000 YR Other