BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHROMAFARE D660 PLUS LIGHTHEAD

    MDR report key: 720602 · Received May 5, 2006

    Report

    Report Number
    MW1039046
    Event Type
    Injury
    Date Received
    May 5, 2006
    Date of Event
    April 18, 2006
    Report Date
    May 5, 2006
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FQP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    BETADINE PREP DONE PRE PROCEDURE, BETADINE WASHED OFF WITH NORMAL SALINE BY SURGEON PRIOR TO START. FOR THE PROCEDURE TWO D660 LIGHTS WERE USED TO ILUMINATE AREAS. THEY WERE PLACED 3.5 FEET AWAY FROM INFANT. THREE HOURS INTO PROCEDURE -10:30-, SURGEON NOTED RED AREA QUARTER SIZE ON LEFT BUTTOCK, CLINICAL COORDINATOR CALLED TO ROOM. SHE OBSERVED RED AREA QUARTER SIZE NOTED WITH BLISTER IN THE CENTER, SHE PLACED HER HAND DIRECTLY ON THE LIGHT, ALTHOUGH IT WAS WARM TO TOUCH SHE COULD LEAVE HER HAND ON THE SURFACE. LIGHTS WERE MOVED FARTHER AWAY FROM PT, 4 FEET. EXPOSED AREA COVERED WITH STERILE BLUE TOWEL. AREA WAS COVERED WITH SILVADENE AND INFANT WAS TAKEN TO PACU. RISK SPECIALIST WASN'T NOTIFIED UNTIL THE CASE WAS OVER AND PT WAS IN PACU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMAFARE D660 PLUS LIGHTHEAD SURGICAL LIGHT FQP BERCHTOLD CORP D660 *
    2 CHROMAFARE D660 PLUS LIGHTHEAD SURGICAL LIGHT FQP BERCHTOLD CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Hospitalization