UV PHOTOTHERAPY LAMP
Received Feb 2, 2021 · Event occurred Jan 14, 2021
Report MW5099163 · MDR key 11272503
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
Angel Kiss LlcProduct problems
- Use of Device Problem
- Patient-Device Incompatibility
Patient
Not reported
- Burn, Thermal
- Burn, Thermal
Narrative
Description of Event or Problem
BURNED PEOPLE SKIN; 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. FDA SAFETY REPORT ID# (B)(4).