BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPERTI SUNLAMPS

    MDR report key: 10106788 · Received June 1, 2020

    Report

    Report Number
    1022129-2020-00001
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 1, 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

    Description of Event or Problem · 1

    THE DEVICE USER REPORTED A CASE OF FACIAL BURN AND CONJUNCTIVITIS AFTER USING THE FIJI SUN TANNING LAMP. THE USER ACKNOWLEDGED SHE READ AND UNDERSTOOD THE DEVICE INSTRUCTIONS FOR USE PRIOR TO USING THE LAMP FOR THE FIRST TIME. HOWEVER, SHE DECIDED TO EXTEND THE SPECIFIED USE TIME FROM 3 MINUTES TO 30 MINUTES. THE USER EXCEEDED THE ALLOWED TIME BY A FACTOR OF 10. ADDITIONALLY, THE USER WAS POSITIONED AT 10-12 INCHES AWAY FROM THE LAMP INSTEAD OF THE RECOMMENDED DISTANCE OF 18 INCHES. THE USER SOUGHT MEDICAL HELP AND OBTAINED EYE DROPS TO TREAT CONJUNCTIVITIS AND PRESCRIPTION ALLERGY MEDICATION BANOPHEN. THE DOCTOR THOUGHT THE COMPLAINANT'S SYMPTOMS MAYBE RELATED TO ALLERGY. NO OTHER TREATMENT WAS ADMINISTERED. THE DEVICE USER FELT BETTER ON DAY 2. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND INSPECTED. THE DEVICE WAS FOUND IN GOOD WORKING ORDER AND NO MALFUNCTIONS WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571035 SPERTI SUNLAMPS FIJI SUN TANNING LAMP LEJ KBD INC. FIJISUN 0719U 00860001660609

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other