BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFT TISSUE MARKER KIT

    MDR report key: 717473 · Received May 20, 2006

    Report

    Report Number
    1932738-2006-00002
    Event Type
    Other
    Date Received
    May 20, 2006
    Date of Event
    February 13, 2006
    Report Date
    May 16, 2006
    Manufacturer
    CIVCO
    Product Code
    NEU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED GOLD MARKER KITS WERE USED FOR PATIENTS BEING TREATED FOR PROSTATE CANCER. RECENTLY, THREE PATIENTS CAME UP WITH URINARY TRACT INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TISSUE MARKER KIT MARKER KIT NEU CIVCO MT-NW-887-835 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other