BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE SPOT PHOTOTHERAPY LIGHT

    MDR report key: 534085 · Received July 14, 2004

    Report

    Report Number
    1121732-2004-00007
    Event Type
    Other
    Date Received
    July 14, 2004
    Date of Event
    June 8, 2004
    Report Date
    July 9, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WHO HAD BEEN TREATED WITH A GIRAFFE SPOT PHOTOTHERAPY LIGHT EXHIBITED ABNORMAL SKIN COLOR. THE REPORT CLAIMED THAT AFTER 48 HOURS OF TREATMENT THE PT SKIN COLOR HAD CHANGED FROM PINK TO VIOLET. THE LIGHT WAS REPORTEDLY POSITIONED 50CM FROM THE PT WITH NO WARMTH DETECTED. AFTER THREE HOURS THE COLOR OF THE PT'S SKIN APPEARED MORE NORMAL. THE PHOTOTHERAPY LIGHT WAS IN PERFECT CONDITION AND WAS USED ON ANOTHER PT WITH NO PROBLEMS REPORTED. IT WAS ALSO REPORTED THAT THE PT HAD FULLY RECOVERED AND THAT AFTER TWO DAYS THE VIOLET COLOR OF THE SKIN HAD DISAPPEARED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE SPOT PHOTOTHERAPY LIGHT PHOTOTHERAPY LBI OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY Other