MalfunctionFTC
UV / PHOTOTHERAPY
Received Aug 13, 2019 · Event occurred May 17, 2019
Report 3013482554-2019-00002 · MDR key 8890818
Device
Generic name
Light, Ultraviolet, Dermatological
Model number
YK-6000BTProduct 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 JUST RECEIVED A UVB WAND AND THE INSTRUCTIONS ARE IN (B)(6)/ENGLISH. I DO NOT KNOW WHERE TO START. I FOUND OUT THAT THE UNIT REQUIRES A PRESCRIPTION FROM MY DR. NO ONE SAID THAT, MY FRIEND SAYS DO NOT USE IT. THERE IS AN INSTRUCTION THAT SAYS IF I GET BURNED, INCREASE TREATMENT TIME AND I AM NOT SURE ABOUT THAT. FDA SAFETY REPORT ID# (B)(4).
Remedial action
- Relabeling
- Other