BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE VTU-1

    MDR report key: 292050 · Received August 22, 2000

    Report

    Report Number
    MW1019760
    Event Type
    Injury
    Date Received
    August 22, 2000
    Date of Event
    November 6, 1998
    Report Date
    August 17, 2000
    Manufacturer
    ENCORE, DIV. OF WETOO, INC.
    Product Code
    LKY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO HELP ERECTILE DYSFUNCTION PROBLEM ON TWO SEPARATE OCCASIONS: RPTR CAUSED PERMANENT DAMAGE TO PENIS, WHEN USING THE ENCORE VTUI ERECTION DEVICE. THE VACUUM PUMP AND CONSTRICTION RINGS SEVERELY BRUISED PENIS, CAUSING A PLAQUE BUILD-UP KNOWN AS PEYRONIE'S DISEASE, WHICH CAUSES A SEVERE CURVATURE TO THE PENIS PREVENTING RPTR FROM HAVING INTERCOURSE WITH HIS WIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE VTU-1 VACUUM ERECTION DEVICE LKY ENCORE, DIV. OF WETOO, INC. NONE NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S