BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 1580035 · Received January 11, 2010

    Report

    Report Number
    2133936-2010-00001
    Event Type
    Injury
    Date Received
    January 11, 2010
    Date of Event
    December 14, 2009
    Report Date
    January 13, 2010
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES HAVE BEEN RETURNED, THEREFORE, NO DIRECT PRODUCT ANALYSIS IS AVAILABLE. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH STANDARD PROCEDURES AND THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE. NO COMMUNICATION WAS OBTAINED DIRECTLY FROM THE PHYSICIAN; HOWEVER, INFO RECEIVED FROM THE MOBILE APPLICATION SPECIALIST REVEALED THAT EVERYTHING WITH THE TREATMENT WAS FINE BUT THE PT WAS NERVOUS AND HAD NOTHING TO EAT FOR BREAKFAST. THE PT WAS ALERT AND AMBULATORY AND REFUSED TO CONTINUE TREATMENT.

    Description of Event or Problem · 1

    PT EXPERIENCED A VASOVAGAL REACTION DURING A TRANSURETHRAL MICROWAVE TREATMENT. THE TREATMENT WAS STOPPED, AND THE PT DECIDED TO DISCONTINUE TREATMENT. HE WAS ALERT, AMBULATORY AND HAD NO APPARENT INJURY. OTHER THAN THE PT'S REACTION, THE TREATMENT WAS UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS SYSTEM MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. TC1121C 091030MCA1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other