ANGEL & KISS UV PHOTOTHERAPY
Received Jan 26, 2021 · Event occurred Jan 14, 2021
Report MW5099030 · MDR key 11236527
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
Angel Kiss Care Co., Ltd.Product problems
- Patient-Device Incompatibility
Patient
Not reported
- 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), WWW.AMAZON.COM/DP/B06XCGGJ7C. 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).