UV PHOTOTHERAPY
Received Jan 21, 2021 · Event occurred Jan 17, 2021
Report MW5098937 · MDR key 11214181
Device
Generic name
Light, Ultraviolet, Dermatological
Product problems
- Use of Device Problem
Patient
28 YR
- Burn, Thermal
- Burn, Thermal
Narrative
Description of Event or Problem
I AM A DERMATOLOGIST AND RECEIVED A PATIENT SUFFERING FROM PSORIASIS. HE WAS BURNED HEAVILY BY A PRODUCT FROM (B)(6) AND HAD TO GO TO HOSPITAL FOR RECOVERY. I HAVE CHECKED THAT THE PRODUCT IS A PSORIASIS LAMP WHICH WILL CAUSE SEVERE BURNING TO PEOPLE IF THEY DO NOT USE THIS LAMP UNDER THE DIRECTION OF A LICENSED PHYSICIAN. THAT IS A PRESCRIPTION (RX) MEDICAL DEVICE AND SHOULD NOT BE AVAILABLE ONLINE WITHOUT PRESCRIPTION. I AM SHOWING YOU THE LINK OF THIS DEVICE ON (B)(6). FDA SHOULD REQUIRE (B)(6) TO REMOVE THIS DEVICE FROM ITS WEBSITE TO AVOID MORE BURNING AND HURT FROM PSORIASIS PATIENT.