BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPERTI SUNLAMPS

    MDR report key: 10250166 · Received July 9, 2020

    Report

    Report Number
    1022129-2020-00002
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    March 28, 2020
    Report Date
    July 6, 2020
    Manufacturer
    KBD INC.
    Product Code
    LEJ
    UDI-DI
    00860001660609
    PMA / PMN Number
    K151721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ALLEGES SHE RECEIVED A BURN AFTER USING THE DEVICE FOR THE FIRST TIME. CUSTOMER STATED SHE READ AND UNDERSTOOD THE USER MANUAL. THE USER MANUAL STATES THAT YOU SHOULD USE THE DEVICE FOR 3 MINUTES MAXIMUM THE FIRST TIME. HOWEVER, THE CUSTOMER STATED SHE USED THE DEVICE FOR THREE 15 MINUTE CYCLES ON THE FRONT OF HER BODY (A TOTAL OF 45 MINUTES ON THE FRONT) AND TWO 15 MINUTE CYCLES ON THE BACK OF HER BODY (A TOTAL OF 30 MINUTES ON THE BACK).

    Description of Event or Problem · 1

    CUSTOMER ALLEGES SHE RECEIVED A BURN AFTER USING THE FIJI SUN TANNING LAMP THE FIRST TIME FOR THREE 15 MINUTES CYCLES ON THE FRONT OF HER BODY AND TWO 15 MINUTE CYCLES ON THE BACK OF HER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719301 SPERTI SUNLAMPS FIJI SUN TANNING LAMP LEJ KBD INC. FIJISUN 0719U 00860001660609

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other