BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROSTATRON

    MDR report key: 970810 · Received December 28, 2007

    Report

    Report Number
    2133936-2007-00022
    Event Type
    Other
    Date Received
    December 28, 2007
    Report Date
    December 28, 2007
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE HAS BEEN RETURNED; THEREFORE, NO DIRECT PRODUCT ANALYSIS WILL BE AVAILABLE. AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A TRANSURETHRAL MICROWAVE TREATMENT PROCEDURE, THE PT WAS SENT TO THE HOSP AND REQUIRED SEVERAL UNITS OF BLOOD. NO FURTHER INFO WAS RECEIVED. IT IS NOTED THAT MULTIPLE ATTEMPTS TO GATHER FURTHER INFO WERE UNSUCCESSFUL. NO FURTHER PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON MICROWAVE DELIVERY SYSTEM MEQ UROLOGIX, INC. 220983 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization