BEUDAMED
    FDA Adverse Event Other Summary report: N

    TARGIS SYSTEM

    MDR report key: 874734 · Received July 3, 2007

    Report

    Report Number
    2133936-2007-00016
    Event Type
    Other
    Date Received
    July 3, 2007
    Date of Event
    November 7, 2006
    Report Date
    July 3, 2007
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. THE DEVICE HISTORY RECORD WAS REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES. THE DEVICE HISTORY RECORD SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. AS NO DEVICE WAS RECEIVED 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 PROCEDURE, THE PATIENT WAS SENT TO THE HOSPITAL FOR EXCESSIVE BLEEDING. THE PATIENT WAS SENT TO THE HOSPITAL DUE TO UNCONTROLLED BLEEDING, HOWEVER, IT IS NOTED THAT THE PATIENT WAS ON COUMADIN, UNKNOWN INTERNATIONAL NORMALIZED RATIO (INR). NO FURTHER PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT IS REPORTED AS FINE, DOING WELL AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 4000A/TC1121 060901MC2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization