BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2250051-2008-00279

    MDR report key: 1113723 · Received May 30, 2008

    Report

    Report Number
    2250051-2008-00279
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO-CLINICAL DIAGNOSTICS (OCD) QA PERFORMED RETAINED TESTING TO CONFIRM THE REACTIVITY. RESULTS WERE SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KSZ

    Patients

    Seq Age Sex Outcome Treatment
    1