BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSTATRON

    MDR report key: 513599 · Received January 14, 2004

    Report

    Report Number
    2133936-2003-00028
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 18, 2003
    Report Date
    January 14, 2004
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING ULTRASOUND PLACEMENT CHECK, BALLOON LOOKED FINE. DURING RAMP UP IT WAS NOTICED THAT BALLOON BROKE. TREATMENT WAS ABORTED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON HYPERTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410053-004 530439

    Patients

    Seq Age Sex Outcome Treatment
    1 *