BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUREKA LINEAR III

    MDR report key: 304031 · Received November 8, 2000

    Report

    Report Number
    1423380-2000-00001
    Event Type
    Injury
    Date Received
    November 8, 2000
    Date of Event
    October 17, 2000
    Report Date
    November 7, 2000
    Manufacturer
    PROGENY, INC.
    Product Code
    IZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COLLIMATOR FELL FROM TUBESTAND DURING A TOMOGRAPHIC EXAMINATION, STRIKING THE PT IN THE FACE. LACERATIONS REQUIRED STITCHES FOR TREATMENT. HOSP REPORTED THREADED HOLE IN MOUNTING COLLAR TO BE STRIPPED. PRODUCT HAS NOT BEEN MADE AVAILABLE TO MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EUREKA LINEAR III COLLIMATOR IZW PROGENY, INC. LINEAR III *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention