BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDASH

    MDR report key: 4946910 · Received July 7, 2015

    Report

    Report Number
    2311923-2015-00002
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 7, 2015
    Report Date
    June 26, 2015
    Manufacturer
    JK PRODUCTS & SERVICES
    Product Code
    LEJ
    Removal / Correction Number
    Z-2635-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN 806 SUBMITTED TO THE (B)(4) DISTRICT OFFICE OF THE FDA.

    Description of Event or Problem · 1

    WE RECEIVED INFORMATION THAT ONE OF OUR DEVICES ALLEGEDLY CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439435 SUNDASH SUNTAN BED LEJ JK PRODUCTS & SERVICES RADIUS 252

    Patients

    Seq Age Sex Outcome Treatment
    1