BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS

    MDR report key: 524408 · Received February 11, 2004

    Report

    Report Number
    2133936-2004-00001
    Event Type
    Other
    Date Received
    February 11, 2004
    Date of Event
    January 8, 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

    AFTER CATHETER WAS INSERTED INTO PATIENT, URINE PORT COULD NOT BE CLEARED. CATHETER WAS REMOVED AND LOOKED LIKE IT HAD FOLDED OVER ALTHOUGH NOTHING DURING INSERTION INDICATED A PROBLEM. NO PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *