BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 638228 · Received August 30, 2005

    Report

    Report Number
    1056128-2005-00004
    Event Type
    Malfunction
    Date Received
    August 30, 2005
    Date of Event
    June 23, 2005
    Report Date
    July 7, 2005
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING SHOULDER ARTHROSCOPY, A DYONICS 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 BLADE HRX VANGUARD MEDICAL CONCEPTS, INC. * 512682

    Patients

    Seq Age Sex Outcome Treatment
    1 *