BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS

    MDR report key: 622852 · Received June 6, 2005

    Report

    Report Number
    2133936-2005-00003
    Event Type
    Malfunction
    Date Received
    June 6, 2005
    Date of Event
    May 4, 2005
    Report Date
    May 31, 2005
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BALLOON WAS TESTED PRE-TREATMENT AND RUPTURED DURING THE TREATMENT. TREATMENT WAS COMPLETED WITH NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS HYPOTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410055-001 050323MC2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN