BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UWE

    MDR report key: 6420904 · Received March 21, 2017

    Report

    Report Number
    1000122259-2017-10002
    Event Type
    Malfunction
    Date Received
    March 21, 2017
    Date of Event
    November 15, 2016
    Report Date
    March 21, 2017
    Manufacturer
    UWE LIGHT GMBH
    Product Code
    RAB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TANNING DEVICE - DURING NORMAL USE IT APPEARS ELECTRICAL SHORT GENERATED AN IGNITION BY ONE OR MORE LAMPS AND HAS CAUSED THE EQUIPMENT TO IGNITE CAUSING THE MATERIAL TO BURN IN THE CANOPY OPERATING AREA WITHIN THE UNIT. THE OPERATING STAFF USING THE FIRE EXTINGUISHER PUT OUT THE FLAMES. FIRE DEPARTMENT CALLED IN TO MAKE INSPECTIONS. NO INJURY OCCURED TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202335 UWE SUNTANNING BED RAB UWE LIGHT GMBH P90C

    Patients

    Seq Age Sex Outcome Treatment
    1