BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 367183 · Received December 17, 2001

    Report

    Report Number
    3032792-2001-00036
    Event Type
    Injury
    Date Received
    December 17, 2001
    Date of Event
    November 19, 2001
    Report Date
    December 17, 2001
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED PAIN IN THEIR LEFT LEG 2 DAYS AFTER THEIR 10TH TREATMENT AND WAS DIAGNOSED WITH ARTERIAL THROMBI. THIS PATIENT HAD A PERSISTENT NON-HEALING ULCER ON THEIR LEFT FOOT INDICATING POSSIBLE VASCULAR DISEASE PATIENT PLATELET COUNT WAS 700,000 AT THE TIME OF THE EVENT AND PATIENT WAS NOT TAKING ASPIRIN. THE PATIENT REQUIRED REMEDIAL FEMORAL POPLITEAL BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56973 PROSORBA COLUMN IMMUNOADSORPTION COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 012301G

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization NSAID, MOVIC.