BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 378106 · Received February 19, 2002

    Report

    Report Number
    MW1024116
    Event Type
    Malfunction
    Date Received
    February 19, 2002
    Date of Event
    January 24, 2002
    Report Date
    February 10, 2002
    Manufacturer
    DYONICS - REPROCESSED BY VANGUARD
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    METAL SHAVINGS NOTED IN CAMERA FIELD OF PT'S KNEE (ARTHROSCOPIC). CANNULA REMOVED AND THOUGHT TO BE "OUT A ROUND".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS ARTHROSCOPIC BLADE 5.5MM HRX DYONICS - REPROCESSED BY VANGUARD 5.5 INCISOR MOCHA *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other