BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTATRON

    MDR report key: 508236 · Received January 5, 2004

    Report

    Report Number
    2133936-2003-00026
    Event Type
    Malfunction
    Date Received
    January 5, 2004
    Date of Event
    November 21, 2003
    Report Date
    January 5, 2004
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PER FIELD EXPERIENCE REPORT SUBMITTED IN 2003: DURING TREATMENT IN 2003 BALLOON RUPTURED UPON INSERTION INTO PT. NEW PROBE WAS USED AND TREATMENT PROCEEDED WITHOUT FURTHER INCIDENT. 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 530397

    Patients

    Seq Age Sex Outcome Treatment
    1 *