BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT

    MDR report key: 485536 · Received September 26, 2003

    Report

    Report Number
    2018492-2003-00018
    Event Type
    Other
    Date Received
    September 26, 2003
    Date of Event
    July 20, 2003
    Report Date
    September 17, 2003
    Manufacturer
    BURTON MEDICAL PRODUCTS
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR VIA BIOMED REPORTED THAT A PT WAS BURNED WHILE UNDERGOING TRIPLE PHOTOTHERAPY FROM A FLOOR MODEL PHOTOTHERAPY LIGHT ON AND OFF ALL DAY. BURN WAS NOTICED BY NURSE AS A RED CIRCLE ON UPPER ABDOMEN/CHEST AREA. AREA WAS TREATED WITH ANTIBIOTIC OINTMENT AND COVERED WITH GAUZE. THE MARK RETURNED TO NORMAL COLOR AND PT WAS RELEASED FROM HOSP. DISCUSSIONS BETWEEN DISTRIBUTOR AND NURSE AND BIOMED, IT WAS REVEALED THAT LIGHT WAS TOO CLOSE TO PT BASED ON THE HOSPITAL'S OWN INSTRUCTIONS AND THE LIGHT WAS USING A BILIBLANKET BULB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT FLOOR MOUNT FSY BURTON MEDICAL PRODUCTS 6600-0029-900 12/93 BURT

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Other