BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1599868 · Received February 4, 2010

    Report

    Report Number
    2133936-2010-00004
    Event Type
    Injury
    Date Received
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS WERE MADE TO SPEAK WITH THE TREATING PHYSICIAN. THE ONLY INFORMATION OBTAINED WAS FROM A NURSE THAT STATED THE EVENT WOULD HAVE OCCURRED MORE THAN 3 YEARS AGO, BEFORE SHE HAS WORKED FOR THE PHYSICIAN. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO SPEAK WITH THE TREATING PHYSICIAN, WE COULD NOT CONFIRM WHETHER THE UROLOGIX TARGIS SYSTEM WAS USED OR WHETHER THE EVENT OCCURRED. ADDITIONALLY, WE DO NOT HAVE INFORMATION ON THE PATIENT, THE TREATMENT, THE EXTENT OF THE PATIENT'S INJURY OR THE CURRENT PATIENT'S STATUS. AT THIS TIME WE DO NOT KNOW WHICH DEVICE MODELS (CATHETER AND CONTROL UNIT) WERE USED IN THE PROCEDURE AND NO DEVICES HAVE BEEN RETURNED; THEREFORE NO DIRECT PRODUCT ANALYSIS IS AVAILABLE.

    Description of Event or Problem · 1

    THE PHYSICIAN INFORMED THE UROLOGIX SALES REPRESENTATIVE OF A PATIENT WHO DEVELOPED A FISTULA AFTER A TARGIS TREATMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other