BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION

    MDR report key: 661830 · Received September 15, 2005

    Report

    Report Number
    2028295-2005-00001
    Event Type
    Malfunction
    Date Received
    September 15, 2005
    Date of Event
    July 18, 2003
    Report Date
    September 15, 2005
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING MICRODERMABRASION PROCEDURE A SURGICAL LIGHT FELL ON A PT, STRIKING HER RIGHT HAND AND LEFT THIGH CAUSING MINOR CUTS. THE PT WAS GIVEN AN X-RAY WITH NO BROKEN BONES NOTED. THE PT WAS TREATED FOR MINOR LACERATIONS AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTURION SURGICAL LIGHT FSY MEDICAL ILLUMINATION INTERNATIONAL, INC. 021514 *

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other