BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1231803 · Received August 18, 2008

    Report

    Report Number
    2250051-2008-00406
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Manufacturer
    *
    Product Code
    KSZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ORTHO CLINICAL DIAGNOSTICS (OCD) QUALITY ASSURANCE PERFORMED RETAINED TESTING TO CONFIRM THE REACTIVITY OF THE E ANTIGENS. RESULTS WERE SATISFACTORY. THE CUSTOMER ALSO REPORTED THE FOLLOWING RELATED INCIDENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1