BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX

    MDR report key: 406225 · Received July 18, 2002

    Report

    Report Number
    8010762-2002-00004
    Event Type
    Malfunction
    Date Received
    July 18, 2002
    Report Date
    July 8, 2002
    Manufacturer
    JOSTRA AG
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WATER LEAKS. NO PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX HOLLOW FIBER MEMBRANE OXYGENATOR DTZ JOSTRA AG * 116941

    Patients

    Seq Age Sex Outcome Treatment
    1 *