BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLENGER SWIVEL KNIFE

    MDR report key: 550877 · Received March 31, 2004

    Report

    Report Number
    550877
    Event Type
    Malfunction
    Date Received
    March 31, 2004
    Date of Event
    December 8, 2003
    Report Date
    March 31, 2004
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KTG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NASAL KNIFE HAD SWIVEL TIP BREAK OFF DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLENGER SWIVEL KNIFE NASAL KNIFE KTG CARDINAL HEALTH RH-761 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR