BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA PHOTOTHERAPY LIGHT

    MDR report key: 502715 · Received December 24, 2003

    Report

    Report Number
    502715
    Event Type
    Other
    Date Received
    December 24, 2003
    Date of Event
    September 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    OHMEDA MEDICAL, (PART OF GE MEDICAL SYSTEMS)
    Product Code
    KGL
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 1 1/2 X 1/2 CM DARK RED AREA WAS NOTED ON ABDOMEN. THE PT WAS ON TRIPLE PHOTOTHERAPY WITH BLANKET, OVERHEAD AND SPOTLIGHT. THE SPOTLIGHT WAS DISCONTINUED. COOL COMPRESSES WERE ORDERED AND APPLIED, AND PERIODICALLY REAPPLIED TO THE EXCORIATED AREA ON THE ABDOMEN UNTIL DISCHARGE. THE LIGHT WAS SENT TO BIOMEDICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA PHOTOTHERAPY LIGHT PHOTOTHERAPY LIGHT KGL OHMEDA MEDICAL, (PART OF GE MEDICAL SYSTEMS) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Other