SPERTI SUNLAMPS
Received Apr 29, 2022 · Event occurred Feb 26, 2022
Report 1022129-2022-00001 · MDR key 14251616
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Additional Manufacturer Narrative
THE USER PURCHASED THE DEVICE ON (B)(6) 2022 VIA (B)(6) MARKETPLACE. SHE CONTACTED US THROUGH (B)(6)'S MESSAGING SYSTEM ON (B)(6) 2022 TO REPORT A BURN. WE HAVE ATTEMPTED TO CONTACT HER THROUGH THE (B)(6)'S MESSAGING SYSTEM TO SPEAK VIA TELEPHONE TO CONDUCT AN INTERVIEW TO GATHER THE NECESSARY INFORMATION FOR THIS MDR FILING. HOWEVER, THE CUSTOMER HAS BEEN UNRESPONSIVE. WE HAVE ADDITIONALLY TRIED TO SEARCH HER NAME, CITY AND STATE VIA (B)(6) TO FURTHER TRY AND CONTACT HER. BUT, WE HAVE BEEN UNSUCCESSFUL. WE HAVE PROVIDED A COPY OF THE USER MANUAL OF THE FIJI SUN TANNING LAMP WHICH INCLUDES A PRODUCT LABEL THAT IS ATTACHED TO THE BACK OF THE DEVICE. THE LABEL AND MANUAL INCLUDES INSTRUCTIONS FOR USE AND EXPOSURE SCHEDULE PER 21 CFR 1040.20. THE BACK DEVICE LABEL INCLUDES WARNINGS OF: ULTRAVIOLET RADIATION. FOLLOW INSTRUCTIONS. AVOID OVEREXPOSURE.' INITIAL EXPOSURE SHOULD NOT EXCEED 3 MINUTES FOR ALL SKIN TYPES AS A DISTANCE OF 18" PER SESSION. EXPOSURE AT A DISTANCE LESS THAN 18" IS NOT RECOMMENDED.' FOLLOW EXPOSURE SCHEDULE FOR APPROPRIATE SKIN TYPE. THE USE OF EXPOSURE POSITION OTHER THAN THE RECOMMENDED DISTANCE MAY RESULTS IN OVEREXPOSURE.'
Description of Event or Problem
THE DEVICE USER REPORTED A BURN AFTER USING THE FIJI SUN TANNING LAMP.