BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 600748 · Received May 5, 2005

    Report

    Report Number
    600748
    Event Type
    Malfunction
    Date Received
    May 5, 2005
    Date of Event
    March 22, 2005
    Report Date
    May 5, 2005
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING A RECYCLED ARTHROSCOPIC BLADE SHAVER, METAL FILINGS AND CHIPS WERE NOTED ON TV CAMERA. THIS SHAVER CUTTER WAS RECYCLED AT VANGUARD MEDICAL CONCEPTS. THE SHAVER WAS REMOVED AND THE COMPANY WAS CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ARTHROSCOPIC SHAVER HRX VANGUARD MEDICAL CONCEPTS, INC. * 530317

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR