BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS

    MDR report key: 502258 · Received December 18, 2003

    Report

    Report Number
    2133936-2003-00027
    Event Type
    Injury
    Date Received
    December 18, 2003
    Date of Event
    July 2, 2003
    Report Date
    December 17, 2003
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FISTULOUS TRACT BETWEEN PROSTRATE AND RECTUM DEVELOPED 20 DAYS AFTER TARGIS TREATMENT FOR BPH. CYTOSTOMY AND PROTOSCOPY PERFORMED IN 2003 TO REPAIR FISTULA. NO FURTHER PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGIS HYPERTHERMIA MICROWAVE/RF SYSTEM MEQ UROLOGIX, INC. 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention