BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS SYSTEM

    MDR report key: 382052 · Received March 14, 2002

    Report

    Report Number
    2133936-2002-00004
    Event Type
    Injury
    Date Received
    March 14, 2002
    Report Date
    March 14, 2002
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED TO REPORT THAT PATIENT EXPERIENCED A RECTAL FISTULA 3 TO 4 WEEKS FOLLOWING A TARGIS TREATMENT. THE FISTULA WAS REPAIRED SURGICALLY. THERE WAS NO INDICATION OF DEVICE MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention