SPERTI SUNLAMPS
Received Jun 1, 2020 · Event occurred May 13, 2020
Report 1022129-2020-00001 · MDR key 10106788
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
20 YR
- Radiation Burn
- Conjunctivitis
- Radiation Burn
- Conjunctivitis
Narrative
Description of Event or Problem
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.