BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOLATE-500

    MDR report key: 5137152 · Received September 14, 2004

    Report

    Report Number
    5137152
    Event Type
    Injury
    Date Received
    September 14, 2004
    Date of Event
    August 21, 2004
    Report Date
    September 9, 2004
    Manufacturer
    FOCUS SURGERY, INC.
    Product Code
    NRZ
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    MR. (B)(6) UNDERWENT HIGH INTENSITY FOCUSED ULTRASOUND TREATMENT OF THE PROSTATE FOR PERSISTENT PROSTATE CANCER ON (B)(6) 2004. THREE WEEKS POSTOPERATIVELY, HE DEVELOPED PROFUSE DIARRHEA AND WAS DIAGNOSED WITH PROSTATIC RECTO-URETHRAL FISTULA. HE WILL NOW REQUIRE COLOSTOMY AND REPAIR. THE HIFU DEVICE, SONABLATE-500 IS UNDER IDE STUDY. THE ADVERSE EVENT IS AN ANTICIPATED EVENT. THE IDE STUDY (B)(4) IS NOW CLOSED ENROLLING PATIENTS AS IT HAS COMPLETED ALLOWABLE NUMBER FOR THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOLATE-500 HIGH INTENSITY FOCUSED ULTRASOUND NRZ FOCUS SURGERY, INC. SONOBLATE-500

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention