BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRALITE FULL BODY PHOTOTHERAPY UNIT

    MDR report key: 335819 · Received June 1, 2001

    Report

    Report Number
    1045025-2001-00001
    Event Type
    Other
    Date Received
    June 1, 2001
    Report Date
    August 6, 1991
    Manufacturer
    ULTRALITE ENTERPRISES, INC.
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    2 PTS RECEIVING TREATMENT BY THE MEDICAL DEVICE RECEIVED 2ND DEGREE, BLISTERING BURNS OVER RANSOM PARTS OF THEIR BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25461 ULTRALITE FULL BODY PHOTOTHERAPY UNIT ULTRAVIOLET DERMATOLOGICAL LIGHT LBI ULTRALITE ENTERPRISES, INC. V4472IV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other