BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 638205 · Received August 30, 2005

    Report

    Report Number
    1056128-2005-00002
    Event Type
    Malfunction
    Date Received
    August 30, 2005
    Date of Event
    June 8, 2005
    Report Date
    June 14, 2005
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    HRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING KNEE ARTHROSCOPY, A DIAGNOSTICS ARTHROSCOPIC BLADE WAS REPORTED TO CAST METAL SHAVINGS INTO THE JOINT SPACE. IRRIGATION WAS USED TO REMOVE SHAVINGS, BUT SOME SHAVINGS WERE LEFT IN THE JOINT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA ARTHROSCOPIC SHAVER HRY VANGUARD MEDICAL CONCEPTS, INC. * 534328

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR