BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA

    MDR report key: 69318 · Received February 14, 1997

    Report

    Report Number
    1221157-1997-00002
    Event Type
    Malfunction
    Date Received
    February 14, 1997
    Date of Event
    February 20, 1996
    Report Date
    February 13, 1997
    Manufacturer
    CONCEPT POLYMER TECHNOLOGIES, INC.
    Product Code
    KGC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USER REPORTED THAT GUIDE WIRE DOES NOT PULL OUT EASILY AND FRAGMENTS DURING REMOVAL. USER STATED THAT IT WAS DIFFICULT TO GUIDE THE TUBE THROUGH MOUNTING PIECE (TO SKIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANDA NEEDLE CATHETER JEJUNOSTOMY KIT, 7 FRENCH KGC CONCEPT POLYMER TECHNOLOGIES, INC. * 71405

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other