BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1160922 · Received July 11, 2008

    Report

    Report Number
    9611369-2008-00560
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    k010667
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBERS. NO SAMPLE IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KDI GAMBRO DIAYLZATOREN GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1