BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICATH C

    MDR report key: 258882 · Received January 10, 2000

    Report

    Report Number
    1218868-2000-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2000
    Date of Event
    June 14, 1999
    Report Date
    January 5, 2000
    Manufacturer
    TREX MEDICAL CORP.
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE A STANDARD REVIEW WAS BEING PERFORMED BY THE BUREAU OF RADIATION CONTROL, THE INSPECTOR MEASURED A MAXIMUM ENTRANCE SKIN EXPOSURE RATE OF 105R/MIN. BIOMEDICAL ENGINEERING STAFF CONFIRMED THIS EXPOSURE RATE USING THEIR OWN EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICATH C X-RAY MACHINE IZO TREX MEDICAL CORP. M182 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA