inforMED
MalfunctionFTC

UV PHOTOTHERAPY INSTRUMENT

Received Aug 13, 2019 · Event occurred May 17, 2019

Report 3013482554-2019-00004 · MDR key 8890816

Device

Generic name

Light, Ultraviolet, Dermatological

Manufacturer

Yonker Medical

Model number

YK-6000BT

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