BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESITE HEMODIALYSIS ACCESS SYSTEM

    MDR report key: 540697 · Received August 26, 2004

    Report

    Report Number
    1225459-2004-00062
    Event Type
    Injury
    Date Received
    August 26, 2004
    Date of Event
    July 19, 2004
    Report Date
    August 26, 2004
    Manufacturer
    VASCA, INC.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MFR WAS INFORMED OF A PT THAT HAD A LATERAL VALVE INFECTION. THERE WAS REDNESS NOTED OVE THE VALVE AND THE PT HAD A FEVER AND A HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESITE HEMODIALYSIS ACCESS SYSTEM BLOOD ACCESS DEVICE MSD VASCA, INC. LHAS14120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention