BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENDEX

    MDR report key: 366177 · Received December 6, 2001

    Report

    Report Number
    MW1023610
    Event Type
    Malfunction
    Date Received
    December 6, 2001
    Report Date
    December 6, 2001
    Manufacturer
    GENDEX CORP
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE X-RAY CAN BE TAKEN SO THAT THE RIGHT AND LEFT SIDES ARE LABELED INCORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55223 GENDEX ORTHO PAN/SEPH 9000 IZO GENDEX CORP A901 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *