BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRALITE 680S PHOTOTHERAPY UNIT

    MDR report key: 2820965 · Received October 31, 2012

    Report

    Report Number
    MW5027456
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ULTRALITE ENTERPRISES INC.
    Product Code
    KGL
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS A PT WHO WAS UNDERGOING PHOTOTHERAPY TREATMENT. FOUR DAYS AFTER THIS TREATMENT, THE PT REPORTED BLISTERING ON HIS THIGHS AND NECK. THE EXPOSED AREA WAS TREATED WITH TOPICAL OINTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE 680S PHOTOTHERAPY UNIT ULTRALITE PHOTOTHERAPY UNIT KGL ULTRALITE ENTERPRISES INC. V48NE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention