BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1820540 · Received August 25, 2010

    Report

    Report Number
    2133936-2010-00015
    Event Type
    Injury
    Date Received
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE DEVICES WERE NOT RETURNED; THEREFORE, NO DIRECT DEVICE ANALYSIS WAS CONDUCTED. THE TREATMENT FILES FOR THIS PT WERE REQUESTED; HOWEVER, NO FILES HAVE BEEN RECEIVED AT THE TIME OF THIS REPORT. AS NO DEVICES AND TREATMENT FILE WERE RETURNED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TRANSURETHRAL MICROWAVE TREATMENT (TUMT) PROCEDURE, THE PHYSICIAN CONFIRMED HIS PATIENT HAD DEVELOPED A RECTAL FISTULA. REPEATED ATTEMPTED TO CONTACT THE PHYSICIAN FAILED TO REVEAL ANY FURTHER INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other