BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDASH

    MDR report key: 2546890 · Received April 16, 2012

    Report

    Report Number
    2311923-2012-00016
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    April 7, 2008
    Report Date
    April 16, 2012
    Manufacturer
    JK PRODUCTS & SERVICE, INC.
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SUBMITTED TO (B)(6).

    Description of Event or Problem · 1

    CLAIMANT ALLEGES TANNING BOOTH CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNDASH RADIUS 252 LEJ JK PRODUCTS & SERVICE, INC. SR 252 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other