BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4113507 · Received September 24, 2014

    Report

    Report Number
    MW5038264
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    June 17, 2013
    Report Date
    September 20, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    #MEDWATCHER #(B)(4). INCREASED CRAMPING, HEIGHTENED OVERALL PHYSICAL SENSITIVITY TO OVULATING, CRAMPING ON BOTH SIDES OF LOWER ABDOMEN, BREAST SWELLING BEYOND USUAL MENSTRUAL SWELLING, INCREASED BLEEDING DURING MENSES, INCREASED CRAMPING OF LOWER ABDOMEN THROUGH HIGHER LEG AREAS TO KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593332 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 40.000 YR Other