BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGIS

    MDR report key: 525675 · Received February 11, 2004

    Report

    Report Number
    2133936-2004-00002
    Event Type
    Malfunction
    Date Received
    February 11, 2004
    Date of Event
    January 13, 2004
    Report Date
    February 10, 2004
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING POSITIONING CHECK PRIOR TO TREATMENT THE BALLOON ON THE CATHETER DEFLATED. BALLOON HAD A HOLE IN IT. NEW CATHETER USED, TREATMENT PROCEEDED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS HYPERTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 410014-002 K008048

    Patients

    Seq Age Sex Outcome Treatment
    1 *