BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPOT PHOTOTHERAPY WALL MOUNT LIGHT

    MDR report key: 449554 · Received March 17, 2003

    Report

    Report Number
    2018492-2003-00009
    Event Type
    Other
    Date Received
    March 17, 2003
    Date of Event
    January 16, 2003
    Report Date
    March 17, 2003
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT A PT WHILE BEING TREATED IN A WARMER WITH 2 SPOT PHOTOTHERAPY LIGHTS 12" - 14" FOR A DURATION OF 1 HOUR AND 15 MINUTES REC'D 2ND DEGREE BURNS ON CHEST. PT WAS TREATED WITH BACITRACIN. PLASTIC SURGEON EVALUATED PT AT TIME OF THE EVENT AND INDICATED NO SCARRING WOULD RESULT. 4 DAYS LATER BURN HEALED WITH NO VISIBLE SCARRING. A BIOMED TECH EVALUATED BOTH LAMPS AND FOUND THAT THEY PASSED ALL SAFETY TESTS: OUTPUT AT 20" WAS FINE, LAMPS FUNCTIONED PERFECTLY, LAMPS WERE IN EXCELLENT WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT PHOTOTHERAPY WALL MOUNT LIGHT WALL MOUNT FSY BURTON MEDICAL PRODUCTS CORP. 6600-0288-901 1-99BURT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other