BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3840229 · Received May 22, 2014

    Report

    Report Number
    MW5036351
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    March 3, 2014
    Report Date
    May 13, 2014
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE RECEIVING ESSURE IMPLANTS, I'VE EXPERIENCED EXTREME CRAMPING AND EXCESSIVE BLEEDING. LONGER AND MORE FREQUENT MENSTRUAL CYCLES RESULTED IN AN ENDOMETRIAL ABLATION PROCEDURE TO CORRECT. THE BLEEDING STOPPED, BUT THE PAIN DID NOT. FREQUENT SHARP/STABBING PAIN ON THE RIGHT SIDE. USUAL DEVELOPMENT OF CYSTS ON LEFT OVARY, RIGHT OVARY, BREAST, CERVIX, AND KIDNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304236 ESSURE ESSURE HHS 744391

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR