BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 2822388 · Received June 20, 2012

    Report

    Report Number
    2133936-2012-00003
    Event Type
    Injury
    Date Received
    June 20, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 10, 2012
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    PMA / PMN Number
    P970008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISPOSABLE DEVICES WILL BE RETURNED BECAUSE THE AE OCCURRED ONE DAY AFTER THE PROCEDURE AND THE CATHETER WAS DISPOSED OF.

    Description of Event or Problem · 1

    ONE DAY AFTER PROCEDURE, PATIENT HAD BLEEDING THAT CONTINUED FOR 1 MONTH. THE PT WAS TAKING COUMADIN AND HAD A CYSTOSCOPY PRE-TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN