BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUXURA

    MDR report key: 18757183 · Received February 22, 2024

    Report

    Report Number
    1000525872-2024-00401
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    July 21, 2022
    Report Date
    February 6, 2024
    Manufacturer
    J&T HEALTH AND WELLNESS LLC
    Product Code
    LEJ
    PMA / PMN Number
    K181455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON JULY 21ST 2022 WE RECEIVED NOTIFICATION THAT ONE OF OUR CUSTOMERS HAD A CLIENT THAT CLAIMED THEY GOT A SUNBURN FROM ONE OF THE TANNING DEVICES THAT WAS AT THEIR LOCATION. THIS TANNING DEVICE BELONG TO OUR COMPANY. THE CLIENT WAS ASKED TO SUBMIT DOCUMENTATION FROM THE DOCTORS OFFICE TO BACK UP THE CLAIM BUT REFUSED TO PROVIDE THE DOCUMENTATION. PROSUN CHECKED OUR QUALITY CONTROL RECORDS AND HAD THE UV OUTPUT VERIFIED. THIS WAS WITHIN RANGE. THE CLIENT WAS REQUESTING A REFUND AND WANTED TO CLOSE OUT THEIR MEMBERSHIP, WHEN PROSUN'S CUSTOMER LOCATION ASKED FOR MORE INFORMATION FROM THEIR CUSTOMER IT WAS REFUSED. THERE WAS NO INFORMATION AVAILABLE STATING WHETHER THE CLIENT HAD BEEN USING TANNING DEVICES IN THE PAST AND HAD BUILT UP A BASE TAN. THERE WAS NO DISCUSSION AVAILABLE TO HAD WITH CLIENT ABOUT THEIR USE OF THE DEVICE OR VERIFICATION OF THE INJURIES THAT THEY HAD. THE CLIENT CONTACTED THE CREDIT CARD PROCESSING COMPANY AND MADE THE CLAIM THAT THEY HAD BEEN BURNED BY THE TANNING DEVICE AND AS SUCH THEY WANTED TO CANCEL THEIR MEMBERSHIP. WHEN REQUESTED TO PROVIDE PROOF OF SUCH BURNS THE CLIENT NO LONGER RESPONDED. THEY REFUSED TO PROVIDE ANY DOCUMENTATION FROM MEDICAL VISITS OR ANY PROOF OF THE BURNS THEY STATED THEY INCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63823 LUXURA V6 LEJ J&T HEALTH AND WELLNESS LLC 48V6

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Other