BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 960298 · Received May 3, 2007

    Report

    Report Number
    1223643-2007-00004
    Event Type
    Malfunction
    Date Received
    May 3, 2007
    Date of Event
    March 26, 2007
    Report Date
    April 26, 2007
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LONG TERM HEMODIALYSIS CATHETER MSD SPIRE BIOMEDICAL, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR