SPERTI SUNLAMPS
Received Jul 9, 2020 · Event occurred Mar 28, 2020
Report 1022129-2020-00002 · MDR key 10250166
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
35 YR
- Burn, Thermal
- Burn, Thermal
Narrative
Additional Manufacturer Narrative
CUSTOMER ALLEGES SHE RECEIVED A BURN AFTER USING THE DEVICE FOR THE FIRST TIME. CUSTOMER STATED SHE READ AND UNDERSTOOD THE USER MANUAL. THE USER MANUAL STATES THAT YOU SHOULD USE THE DEVICE FOR 3 MINUTES MAXIMUM THE FIRST TIME. HOWEVER, THE CUSTOMER STATED SHE USED THE DEVICE FOR THREE 15 MINUTE CYCLES ON THE FRONT OF HER BODY (A TOTAL OF 45 MINUTES ON THE FRONT) AND TWO 15 MINUTE CYCLES ON THE BACK OF HER BODY (A TOTAL OF 30 MINUTES ON THE BACK).
Description of Event or Problem
CUSTOMER ALLEGES SHE RECEIVED A BURN AFTER USING THE FIJI SUN TANNING LAMP THE FIRST TIME FOR THREE 15 MINUTES CYCLES ON THE FRONT OF HER BODY AND TWO 15 MINUTE CYCLES ON THE BACK OF HER BODY.