BEUDAMED
    FDA Adverse Event Other Summary report: N

    POURCHEZ RETRO TWIN LUMEN CATHETER

    MDR report key: 543358 · Received September 9, 2004

    Report

    Report Number
    1223643-2004-00006
    Event Type
    Other
    Date Received
    September 9, 2004
    Report Date
    September 9, 2004
    Manufacturer
    SPIRE BIOMEDICAL, INC.
    Product Code
    MSD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RETRO CATHETER WAS REMOVED AFTER A 5 TO 7 DAY PERIOD OF BEING IMPLANTED. THE PT HAD DEVELOPED A TEMP. CATHETER WAS NOT THE CAUSE OF THE PT'S TEMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POURCHEZ RETRO TWIN LUMEN CATHETER HEMODIALYSIS CATHETER MSD SPIRE BIOMEDICAL, INC. RS23SH28 99403907

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention