BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSTATRON

    MDR report key: 500585 · Received December 9, 2003

    Report

    Report Number
    2133936-2003-00024
    Event Type
    Other
    Date Received
    December 9, 2003
    Date of Event
    July 12, 2002
    Report Date
    November 24, 2003
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED BLADDER STONES APPROXIMATELY ONE YEAR AFTER TRANSURETHRAL MICROWAVE THERMOTHERAPY TREATMENT. STONES WERE REMOVED, AND DOCTOR SUSPECTED THAT STONE MAY HAVE BEEN A CALCIFED PIECE OF BALLOON. NO FURTHER PATIENT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON HYPERTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410053-004 530107

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention