BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0IR-202

    MDR report key: 437497 · Received January 10, 2003

    Report

    Report Number
    1221261-2003-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2003
    Date of Event
    December 9, 2002
    Report Date
    January 7, 2003
    Manufacturer
    LEVEL 1, INC.
    Product Code
    KZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SALES REP. FROM CONMED WAS PERFORMING AN IN-SERVICE ON THE HIR-202, AND WHEN THEY TURNED THE UNIT ON, THE FRONT COVER CAME FLYING OFF AND HIT THEM IN THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0IR-202 PRESSURE INFUSER KZD LEVEL 1, INC. HIR-202 20010022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA