BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 2822389 · Received June 20, 2012

    Report

    Report Number
    2133936-2012-00004
    Event Type
    Injury
    Date Received
    June 20, 2012
    Date of Event
    April 11, 2012
    Report Date
    June 15, 2012
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AE BEGAN AFTER PROCEDURE AND DISPOSABLE CATHETER WAS DISPOSED OF AFTER PROCEDURE.

    Description of Event or Problem · 1

    PATIENT HAD BECOME UROSEPTIC AND WAS ADMITTED INTO THE HOSPITAL AND DIAGNOSED WITH BACTERIAL PROSTATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ANTIBIOTICS FOR 30 DAYS