inforMED
InjuryFTC

PSORIASIS UV PHOTOTHERAPY LAMP

Received Feb 3, 2021 · Event occurred Jan 18, 2021

Report MW5099212 · MDR key 11278741

Device

Generic name

Light, Ultraviolet, Dermatological

Manufacturer

Angel Kiss Llc.

Product problems

  • Patient-Device Incompatibility

Patient

Not reported

  • Erythema
  • Skin Burning Sensation
  • Erythema
  • Skin Burning Sensation

Narrative

Description of Event or Problem

I AM A PHYSICIAN AND GOT A PSORIASIS PATIENT RECENTLY. HE USED A LAMP FROM (B)(6) BUT GOT BURNED DEADLY. THE LAMP CAUSES INCREASED BURNING AND REDNESS TO HIS ELBOW PSORIASIS. HE HAD TO STOP USING AFTER 2 DAYS AND THOROUGHLY WASH SKIN TO ALLEVIATE INTENSE BURNING. THE LAMP IS A IS A PRESCRIPTION (RX) MEDICAL DEVICE WHICH CLEARLY SHOWS IN ITS PACKAGE AND MANUAL. I THINK (B)(6) IS FORBIDDEN TO SELL THIS ONLINE WITHOUT PRESCRIPTION. THE LINK OF THE LAMP IS (B)(6). (B)(6) SHOULD REMOVE THIS. FDA SAFETY REPORT ID# (B)(4).