inforMED
InjuryFTC

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 Llc

Product 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).