BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOLYTH INTEGRATED MEMBRANE LUNG

    MDR report key: 285244 · Received July 7, 2000

    Report

    Report Number
    1718850-2000-00016
    Event Type
    Malfunction
    Date Received
    July 7, 2000
    Date of Event
    May 5, 2000
    Manufacturer
    SORIN BIOMEDICAL, INC.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOLYTH INTEGRATED MEMBRANE LUNG BLOOD OXYGENATOR AND VENOUS RESERVOIR DTZ SORIN BIOMEDICAL, INC. 78958D

    Patients

    Seq Age Sex Outcome Treatment
    1