BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPOT

    MDR report key: 598126 · Received April 26, 2005

    Report

    Report Number
    598126
    Event Type
    Malfunction
    Date Received
    April 26, 2005
    Date of Event
    April 20, 2005
    Report Date
    April 26, 2005
    Manufacturer
    GI SUPPLY
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE INJECTING INDIA INK, THE SYRINGE BROKE SPATTERING INK ON PATIENT AND STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT ENDOSCOPIC MARKER KOG GI SUPPLY GIS-44 010405 01/07

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR