BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINENTAL UROMAT

    MDR report key: 130717 · Received November 3, 1997

    Report

    Report Number
    MW1012442
    Event Type
    Injury
    Date Received
    November 3, 1997
    Date of Event
    October 9, 1997
    Report Date
    October 29, 1997
    Manufacturer
    TREX MEDICAL CORP.
    Product Code
    MMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN OR FOR CYSTO-RETROGRADE & POSITIONING OF STENT PROCEDURE. DURING PROCEDURE THE FLUROSCOPY FAILED, SWITCHES TO CONVENTIONAL X-RAY RPTR WAS UNABLE TO TAKE REGULAR X-RAY DUE TO MALFUNCTION OF THE X-RAY GENERATOR. THESE MALFUNCTIONS MADE IT DIFFICULT TO COMPLETE. DURING PROCEDURE THE GENERATOR DISPLAYED "SYSTEM 33 FLAG ERROR" "HIGH KV".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINENTAL UROMAT RADIOGRAPHIC FLUOROSCOPIC MMZ TREX MEDICAL CORP. UROMAT 2000,TM40 RF-GENERATOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L