BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRALITE PHOTOTHERAPY UNIT

    MDR report key: 2869659 · Received December 10, 2012

    Report

    Report Number
    1045025-2012-00001
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 8, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ULTRALITE ENTERPRISES, INC.
    Product Code
    KGL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UEI CONTACTED (B)(4). (B)(6) SPOKE TO (B)(6) AND FOUND THE UNIT WAS REFERENCED AND CALIBRATED CORRECTLY THAT IT WAS A STAFF ERROR. OUR CONVERSATION CONFIRMED THAT THE MACHINE WAS OPERATING PROPERLY AND NO OTHER INCIDENT HAD TAKEN PLACE.

    Description of Event or Problem · 1

    UEI BECAME AWARE OF AN EVENT THAT OCCURRED ON (B)(6) 2012, ON (B)(4) 2012 BY A REPORT FROM MEDWATCH. THE REPORT STATES A PT WAS UNDERGOING A PHOTOTHERAPY AND FOUR DAYS AFTER THE TREATMENT THE PT HAD BLISTERING ON HIS THIGHS AND NECK. IT WAS DECIDED A MDR SHOULD BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRALITE PHOTOTHERAPY UNIT ULTRALITE PHOTOTHERAPY UNIT KGL ULTRALITE ENTERPRISES, INC. V4848NB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention