InjuryFTC
YONKER UV PHOTOTHERAPY LAMP
Received Aug 13, 2019 · Event occurred Feb 12, 2019
Report 3013482554-2019-00005 · MDR key 8890812
Device
Generic name
Light, Ultraviolet, Dermatologial
Model number
YK-6000BTProduct problems
- Improper or Incorrect Procedure or Method
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Skin Irritation
- Skin Irritation
Narrative
Description of Event or Problem
I AM A PATIENT HAS PSORIASIS ON ARM. I BOUGHT A UVB LAMP ON (B)(6), THE LINK IS (B)(6). I USED, ACCORDING TO THEIR MANUAL, THE MANUAL SAID IT SHOULD BE USED UNDER PHYSICIAN'S GUIDE, BUT WHEN I BOUGHT IT, IT HADN'T BEEN NOTICED. I USED IT AT HOME BY MYSELF, AFTER 2 TIMES IRRITATION MY SKIN GOT DEEP RED AND HURT LIKE A BURN. I COMPLAINED TO (B)(6) AND THE SELLER, THEY SAID THIS IS A PRESCRIPTION MEDICAL DEVICE.
Remedial action
- Relabeling
- Other