BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS

    MDR report key: 528746 · Received February 25, 2004

    Report

    Report Number
    2133936-2004-00003
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    January 29, 2004
    Report Date
    February 25, 2004
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    UPON INSERTION INTO THE BLADDERNECK, THE CATHETER BALLOON BURST. NEW CATHETER USED, TREATMENT PROCEEDED WITHOUT FURTHER INCIDENT. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS HYPOTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410033-001 KG123003

    Patients

    Seq Age Sex Outcome Treatment
    1 *