BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 90616 · Received May 9, 1997

    Report

    Report Number
    3023288-1997-00005
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    February 10, 1997
    Report Date
    May 9, 1997
    Manufacturer
    CYPRESS BIOSCIENCE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WITH A DIAGNOSIS OF CHRONIC IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP) RECEIVED SIX COLUMN TREATMENTS IN EARLY JANUARY 1997. SUBSEQUENTLY, THE PT ALSO RECEIVED ADDITIONAL IV IGG. ON 02/10/97 DURING A FOLLOWUP, IT WAS NOTED THAT THE PT HAS TENDER, COOL FINGERTIPS. THE THUMB AND INDEX FINGER OF THE PT'S RIGHT HAND ARE DEFINETELY ISCHEMIC. THE CONDITION PERSISTS AND THE PT HAS HAD AN ANGIOGRAM WHICH SHOWS SMALL VESSEL DISEASE. FURTHER INFORATION OF 05/05/97 IS THAT THE PT'S PLATLET COUNT IS UP AT 84,000. THE PT'S BATTLE WITH FINGER AND THUMB CONTINUES AND SHE MAY LOSE THE TIP OF THE THUMB. PT IS BEING TREATED WITH HYPERBERIC OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROTEIN A IMMUNOADSORPTION COLUMN LQQ CYPRESS BIOSCIENCE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other