MalfunctionFTC
UV PHOTOTHERAPY INSTRUMENT
Received Aug 13, 2019 · Event occurred May 17, 2019
Report 3013482554-2019-00004 · MDR key 8890816
Device
Product problems
- Inadequate Instructions for Non-Healthcare Professional
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
I PURCHASED A UV PHOTOTHERAPY DEVICE FOR THE TREATMENT OF PSORIASIS. THE INSTRUCTIONS ARE VERY POOR. LIKE A MIX OF CHINESE AND ENGLISH. AFTER LOOKING AROUND IN THE INTERNET, I LEARNED THAT I SHOULD HAVE BEEN ASKED FOR A PRESCRIPTION BEFORE BEING ALLOWED TO PURCHASE THIS PRODUCT. THIS IS NOT A OVER THE COUNTER DEVICE. I AM AFRAID TO USE IT BECAUSE SOME INSTRUCTIONS INDICATE THAT YOU SHOULD INCREASE THE TREATMENT TIME IF YOU ARE GETTING A SUNBURN. THIS DOES NOT SOUND RIGHT. I THINK THE FDA NEEDS TO BE AWARE OF THIS. FDA SAFETY REPORT ID# (B)(4).
Remedial action
- Relabeling
- Other