BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRALITE PHOTO THERAPY UNIT

    MDR report key: 393712 · Received May 10, 2002

    Report

    Report Number
    1045025-2002-00002
    Event Type
    Other
    Date Received
    May 10, 2002
    Date of Event
    December 1, 2001
    Report Date
    May 10, 2002
    Manufacturer
    ULTRALITE ENTERPRISES INC
    Product Code
    FTC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED UEI (05/08/2002) FOR CALIBRATION SERVICE OF THEIR UNIT. DURING THE DISCUSSION OF SCHEDULING, REPORTER INFORMED UEI OF A PT (UNKNOWN) WHO WAS BURNED SEVERELY IN DEC. REPORTER HAD LITTLE DETAIL ON THE EVENT. REPROTER DID SAY THAT THE PT WAS SUING THE USER FACILITY. REPORTER INFORMED THE COMPANY THAT THE UNIT HAS CONTINUED TO BE USED SINCE DECEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE PHOTO THERAPY UNIT UV DERMATOLOGY LIGHT FTC ULTRALITE ENTERPRISES INC V4408 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other