BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGIS

    MDR report key: 516783 · Received March 18, 2004

    Report

    Report Number
    2133936-2004-00004
    Event Type
    Injury
    Date Received
    March 18, 2004
    Date of Event
    January 30, 2004
    Report Date
    March 17, 2004
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED TARGIS TREATMENT IN 2004. TREATMENT WENT WELL. APPROX TWO WEEKS AFTER THE TREATMENT PT HAD PROSTATIC HEMORRAGING AND CLOTS IN THE BLADDER. PT WAS CAUTERIZED AND HOSPITALIZED FOR 2-3 DAYS. PT HAS FULLY RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization