BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRALITE 6809 FULL BODY PHOTOTHERAPY UNIT

    MDR report key: 335822 · Received June 1, 2001

    Report

    Report Number
    1045025-2001-00002
    Event Type
    Other
    Date Received
    June 1, 2001
    Report Date
    November 13, 1996
    Manufacturer
    ULTRALITE ENTERPRISES, INC.
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    3 PTS RECEIVED 2ND DEGREE BURNS WHILE RECEVING TREATMENT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25539 ULTRALITE 6809 FULL BODY PHOTOTHERAPY UNIT ULTRALITE DERMATOLOGICAL LIGHT LBI ULTRALITE ENTERPRISES, INC. V4412AB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other