BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UWE

    MDR report key: 6419475 · Received March 20, 2017

    Report

    Report Number
    1000122259-2017-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    August 8, 2016
    Report Date
    March 17, 2017
    Manufacturer
    UWE LIGHT GMBH
    Product Code
    RAB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO LONGER IN BUSINESS SINCE AUGUST 2015.

    Description of Event or Problem · 1

    TANNING DEVICE - DURING NORMAL USE IT APPEARS ELECTRICAL SHORT GENERATED AN IGNITION BY ONE OR MORE LAMPS HAS CAUSED THE EQUIPMENT TO IGNITE CAUSING THE MATERIAL TO BURN IN THE CANOPY OPERATING AREA WITHIN THE UNIT. FIRE DEPARTMENT EXTINGUISHED THE FIRE. NO INJURY OCCURED TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201852 UWE SUNTANNING BED RAB UWE LIGHT GMBH P90C

    Patients

    Seq Age Sex Outcome Treatment
    1