BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL ILLUMINATION INTERNATIONAL, INC.

    MDR report key: 420509 · Received October 7, 2002

    Report

    Report Number
    2028295-2002-00001
    Event Type
    Injury
    Date Received
    October 7, 2002
    Date of Event
    July 24, 2001
    Report Date
    September 25, 2002
    Manufacturer
    MEDICAL ILLUMINATION INTERNATIONAL, INC.
    Product Code
    KZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE LIGHT BULB IN THIS LIGHT FAILED EITHER DURING OR BEFORE THE PROCEDURE BEGAN. A DOCTOR AT THE FACILITY WENT TO REPLACE THE BULB, BUT INSTEAD OF REMOVING THE HANDLE BASE SCREWS AS SPECIFIED IN THE LAMP REPLACEMENT PROCEDURE, HE REMOVED THE SPRINGS THAT HOLD THE HEAT FILTER IN PLACE AND REMOVED THE FILTER. THE BULB WAS REPLACED, BUT THE FILTER WAS NOT REPLACED. THE LIGHT WAS THEN USED ON THE PT, WITHOUT THE HEAT FILTER IN PLACE. DURING THE BREAST AUGMENTATION SURGERY, THE PT SUSTAINED BILATERAL THIRD DEGREE BURNS TO THEIR BREASTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICAL ILLUMINATION INTERNATIONAL, INC. ILLUMINATOR III KZF MEDICAL ILLUMINATION INTERNATIONAL, INC. 011314-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA