BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 638218 · Received August 30, 2005

    Report

    Report Number
    1056128-2005-00003
    Event Type
    Malfunction
    Date Received
    August 30, 2005
    Date of Event
    June 23, 2005
    Report Date
    August 4, 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, AN ARTHROSCOPIC BLADE 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 HRX VANGUARD MEDICAL CONCEPTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *