BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXL4 LEUKOCYTE REDUCTION FILTER FOR PLATELETS TRANSFUSN

    MDR report key: 107873 · Received July 25, 1997

    Report

    Report Number
    2432733-1997-00032
    Event Type
    Other
    Date Received
    July 25, 1997
    Date of Event
    June 14, 1997
    Report Date
    June 27, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED HYPOTENSION AND URTICARIA DURING A PC TRANSFUSION THROUGH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PXL4 LEUKOCYTE REDUCTION FILTER FOR PLATELETS TRANSFUSN LEUKOCYTE REDUCTION FILTER FOR PLATELETS CAK PALL BIOMEDICAL PRODUCTS CO. PXL4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention