BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS MDS

    MDR report key: 592882 · Received April 7, 2005

    Report

    Report Number
    2133936-2005-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2005
    Date of Event
    March 23, 2005
    Report Date
    April 7, 2005
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RECEIVED CALL TO REPORT THAT IN THE MIDDLE OF TREATMENT, THE PATIENT COMPLAINED THAT IT WAS PAINFUL AND THE DOCTOR NOTICED THERE WAS WATER COMING OUT FROM THE BALLOON. REPLACED THE CATHETER AND TREATMENT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS MDS HYPERTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410014-002 040908MC2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other