BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOLOCOTRANS PLUS

    MDR report key: 76835 · Received March 13, 1997

    Report

    Report Number
    1213643-1997-00021
    Event Type
    Death
    Date Received
    March 13, 1997
    Report Date
    March 13, 1997
    Manufacturer
    DAVOL, INC.
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER REINJECTION OF 500 CC OF BLOOD, THE PT LOST A LOT OF BLOOD VIA DRAIN. (5 HOURS LATER). THE COMPLAINT REPORT STATES "PT DIED BUT CO DOES NOT KNOW IF IT IS FOLLOWING AUTOTRANSFUSION USING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOCOTRANS PLUS AUTOTRANSFUSION APARATUS CAC DAVOL, INC. NA 41KEDS09

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death