BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSORBA COLUMN

    MDR report key: 532107 · Received June 25, 2004

    Report

    Report Number
    3032792-2004-00005
    Event Type
    Injury
    Date Received
    June 25, 2004
    Date of Event
    May 25, 2004
    Report Date
    June 23, 2004
    Manufacturer
    FRESENIUS HEMOCARE, INC.
    Product Code
    LQQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN RA PATIENT DEVELOPED A SUBCLAVIAN DVT AT THE SITE OF A CENTRAL LINE THAT HAD BEEN PLACED FOR PROSORBA TREATMENT. PATIENT HAD RECEIVED THEIR FIRST TREATMENT EARLIER IN THE DAY AND WAS ADMITTED TO THE HOSPITAL THAT EVENING. ANGIOPLASTY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSORBA COLUMN PROSORBA COLUMN LQQ FRESENIUS HEMOCARE, INC. 9798701 PGN001A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 3. PREMARIN,| 1. PREDNISONE,| 2. ASPIRIN,| 4. NEURONTIN,| 5. SYNTHROID