BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RCXL-1Y

    MDR report key: 161515 · Received April 8, 1998

    Report

    Report Number
    MW1013448
    Event Type
    Injury
    Date Received
    April 8, 1998
    Date of Event
    March 25, 1998
    Report Date
    April 8, 1998
    Manufacturer
    KOL BIOMEDICAL INSTRUMENTS, INC.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER A TRANSFUSION OF TWO UNITS PACKED RED BLOOD CELLS ON 1/18/1998, PT EXPERIENCED "RED EYE SYNDROME." SYMPTOMS INCLUDE TEARING AND ITCHING OF EYES. TO DATE, CONDITION STILL PERSISTS AND HAS NOT RESOLVED. THE REP WAS CONTACTED ON 4/6/1998. BLOOD BANK DIRECTOR HAS ALSO CONTACTED THE CENTERS FOR DISEASE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RCXL-1Y BLOOD FILTER CAK KOL BIOMEDICAL INSTRUMENTS, INC. NI 729505, 729705

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR