BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTATRON 30 MINUTE TUMT

    MDR report key: 479804 · Received August 18, 2003

    Report

    Report Number
    MW1029363
    Event Type
    Injury
    Date Received
    August 18, 2003
    Date of Event
    August 6, 2003
    Report Date
    August 18, 2003
    Manufacturer
    UROLOGIX, INC.
    Product Code
    MEQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    TUMT BY PROSTATRON. URETHRAL HEMORRHAGE, PROSTATIC URETHRAL MUCOSAL LACERATIONS, ACUTE URINARY RETENTION, INABILITY TO PASS FOLEY CATHETER. REQUIRING SUPRAPUBIC TUBE, SUBSEQUENT EMERGENT TURP, 2 UNITS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTATRON 30 MINUTE TUMT PROSTATIC SURGERY MEQ UROLOGIX, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R BLUE CATHETER.