BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTRATRON

    MDR report key: 500385 · Received November 26, 2003

    Report

    Report Number
    2133936-2003-00022
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Date of Event
    July 22, 2003
    Report Date
    November 24, 2003
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    TEN MINUTES INTO TREATMENT THE BALLOON BURST. A NEW PROBE WAS THEN USED AND TREATMENT PROCEEDED WITHOUT FURTHER INCIDENT. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTRATRON HYPOTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410053-004 530326

    Patients

    Seq Age Sex Outcome Treatment
    1 *