BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRALITE FULL BODY PHOTOTHERAPY UNIT

    MDR report key: 386331 · Received April 2, 2002

    Report

    Report Number
    1045025-2002-00001
    Event Type
    Other
    Date Received
    April 2, 2002
    Date of Event
    March 21, 2002
    Report Date
    April 1, 2002
    Manufacturer
    ULTRALITE ENTERPRISES INC.
    Product Code
    KGL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NEW CLINICAL STAFF MEMBER KEYED IN A 13 MINUTE TREATMENT INSTEAD OF 1 MINUTE 30 SECONDS SPECIFIED FOR A UVB TREATMENT. TREATMENT WAS SHOPPED AFTER APPROXIMATELY 5 MINUTES. EVENT WAS CAUSED BY OPERATOR ERROR. LAST WEEK DR BEGAN UVB TREATMENTS ON PT. UVB TIME FOR FIRST TREATMENT WAS 1 MINUTE. IN 2002, DURING SECOND TREATMENT, A NEW CLINICAL STAFF MEMBER WAS TO ADVANCE THE TIME TO 1.30 MINUTES. INSTEAD, STAFF MEMBER KEYED 13 MINUTES. STAFF MEMBER ASKED ANOTHER STAFF MEMBER TO CHECK WHAT STAFF MEMBER HAD KEYED AND THE SECOND MORE EXPERIENCED EMPLOYEE, IMMEDIATELY STOPPED THE PUVA MACHINE AT A LITTLE OVER 5 MINUTES. THE PATIENT WAS QUESTIONED AND REPORTED THEY WERE FINE. THE PATIENT WAS SEEN AGAIN TODAY AND PRESENTED WITH 2ND DEGREE BURNS. DR SPOKE AT LENGTH WITH THE PATIENT AND REPORTER DID A FOLLOW-UP TELEPHONE CALL. PT UNDERSTANDS THIS WAS AN OPERATOR ERROR. REPORTER WILL BE TALKING WITH THIS PATIENT AGAIN ON MONDAY TO SEE HOW THEY ARE DOING. PT ALSO HAS ANOTHER APPT WITH DR NEXT THURSDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE FULL BODY PHOTOTHERAPY UNIT UV DERMATOLOGY LIGHT KGL ULTRALITE ENTERPRISES INC. V4824TL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other