BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTATRON SYSTEM

    MDR report key: 1617939 · Received February 23, 2010

    Report

    Report Number
    2133936-2010-00005
    Event Type
    Injury
    Date Received
    February 23, 2010
    Report Date
    February 21, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES HAVE BEEN RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. NO COMMUNICATION WAS OBTAINED DIRECTLY FROM THE PHYSICIAN.

    Description of Event or Problem · 1

    PATIENT WAS ATTEMPTING TO AVOID SURGERY FOR TREATING HIS BPH SO HE UNDERWENT TUMT WITH A PROSTATRON SYSTEM. THE PATIENT NOW COMPLAINS OF INABILITY TO EMPTY HIS BLADDER 8 WEEKS POST TREATMENT. HIS UROLOGIST NOW ADVISES SURGICAL TREATMENT FOR HIS BPH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other