BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1696130 · Received May 18, 2010

    Report

    Report Number
    2133936-2010-00010
    Event Type
    Injury
    Date Received
    May 18, 2010
    Report Date
    May 14, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISPOSABLE DEVICES WERE RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. THE TREATMENT FILE PRINTOUT FROM THE CONTROL UNIT WAS OBTAINED AND REVIEWED ALONG WITH THE CATHETER DEVICE HISTORY RECORD. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE TO STANDARD PROCEDURES, AND THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. AS NO DEVICE WAS RETURNED FOR ANALYSIS AND THE TREATMENT FILE DEMONSTRATES THE CONTROL UNIT OPERATED APPROPRIATELY, 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 PROCEDURE, THE PATIENT WAS DIAGNOSED WITH EPIDIDYMITIS. THE EPIDIDYMITIS HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 5000A 100202MCA2

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability