BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS550S CRYOSTORE FREEZINGBAG

    MDR report key: 20402001 · Received October 8, 2024

    Report

    Report Number
    1000160256-2024-00007
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    August 28, 2024
    Report Date
    October 8, 2024
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    KSR
    UDI-DI
    10816203021349
    PMA / PMN Number
    BK030036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. ORIGEN HAS REACHED OUT TO OUR SUPPLIER FOR ADDITIONAL INFORMATION ABOUT ALUMINUM COMPONENTS IN THEIR FACILITY.

    Description of Event or Problem · 0

    A FREE-FLOATING ALUMINUM PARTCLE WAS FOUND IN THE FINAL PRODUCT FOR KYMRIAH (LENGTH OF THE PARTICLE WAS 422 MICROMETERS). THIS RESULTED IN THE TREATMENT NOT BEING PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686660 CS550S CRYOSTORE FREEZINGBAG CS50S KSR ORIGEN BIOMEDICAL, INC. CSS W23832 10816203021349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other