BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1614432 · Received February 2, 2010

    Report

    Report Number
    2133936-2010-00002
    Event Type
    Injury
    Date Received
    February 2, 2010
    Report Date
    January 28, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN WHAT DEVICES WERE USED IN THE PROCEDURE AND NO DEVICES HAVE BEEN RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. WE WERE UNABLE TO OBTAIN INFO ON THE PT OR THE TREATMENT ALTHOUGH SEVERAL ATTEMPTS WERE MADE TO CONTACT THE TREATING PHYSICIAN. THE EXTENT OF THE PT INJURY AND CURRENT PT STATUS IS UNKNOWN. THE TERRITORY SALES MANAGER FAILED TO INFORM REGULATORY PERSONNEL AT THE TIME OF THE INITIAL PHYSICIAN COMMUNICATION, THEREFORE THIS EVENT WAS NOT FILED WITHIN 30 DAYS OF THE MADE AWARE DATE. UROLOGIX IS INVESTIGATING THIS MISCOMMUNICATION VIA CAPA (B) (4).

    Description of Event or Problem · 1

    PHYSICIAN INFORMED THE UROLOGIX SALES REP DURING A ROUTINE VISIT OF A PATIENT WHO DEVELOPED A FISTULA AFTER A TARGIS TREATMENT. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other