BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANTI-FYA

    MDR report key: 593336 · Received June 4, 2004

    Report

    Report Number
    1034569-2004-00002
    Event Type
    Other
    Date Received
    June 4, 2004
    Date of Event
    April 23, 2004
    Report Date
    June 4, 2004
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANTI-FYA WAS ELUTED FROM THE PT'S CELLS AFTER TRANSFUSION OF MULTIPLE UNITS OF PACKED RED BLOOD CELLS. THE PT DID NOT EXHIBIT SYMPTOMS OF A HEMOLYTIC TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-FYA BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. NA 3B4330

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other