BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EURGOLINE SUN ANGEL 1400 DUO

    MDR report key: 9641873 · Received January 28, 2020

    Report

    Report Number
    MW5092598
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    January 14, 2020
    Report Date
    January 25, 2020
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WANTED TO MAKE YOU AWARE OF A SERIOUS SITUATION AT A TANNING SALON I VISITED THIS EVENING: (B)(6). MOST RECENT FRANCHISE OWNER I COULD LOCATE IS LISTED AS (B)(6). ON (B)(6) 2020 19:05 - 19:25 BED 12 SUN ANGEL ELECTRONIC CONTROL PANEL NON RESPONSIVE, UNABLE TO CONTROL AIR, TEMPERATURE OR TIMING ON TANNING BED. NOTIFIED FRONT DESK CLERK, BLOND, SMALL FRAME, SLIM, ROUGHLY 18-22 Y/O, OF THE ISSUE LISTED ABOVE AS WELL AS MY CONCERNS. SHE INFORMED ME NOTHING SHE CAN DO, MANY CLIENTS WHO CAME IN EARLIER COMPLAINED, SHE WILL INFORM MGR TOMORROW. SHE INSTRUCTED YOUNG BRUNETTE GIRL TO GO CLEAN THE BED. I EXPLAINED THAT SHE IS IN VIOLATION OF USFDA OF CFR TITLE 21 CHAPTER 1 SUB-PART B, THAT IT IS HER LEGAL RESPONSIBLE TO SHUT DOWN MACHINE AND NOT PERMIT FURTHER CLIENTS TO USE. SHE SAID NO, SHE WILL SPEAK WITH HER MGR TOMORROW. I WAS FORTHRIGHT AND INFORMED BOTH YOUNG WOMEN THAT I WOULD BE CONTACTING BOTH THE USFDA AND THE (B)(6) DEPT OF HEALTH, AND IF SHE WAS NOT GOING TO SHUT DOWN THE MACHINE FOR THE EVENING, THAT THE WISEST STEP WOULD BE TO CONTACT HER LEADERSHIP NOW AND NOT WAIT. SHE WAS UNCONCERNED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103183 EURGOLINE SUN ANGEL 1400 DUO BOOTH, SUN TAN LEJ JK PRODUCTS & SERVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention