inforMED
InjuryFTC

UV PHOTOTHERAPHY

Received Feb 2, 2021 · Event occurred Jan 21, 2021

Report MW5099157 · MDR key 11272413

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

IT BURNED SKIN TERRIBLY; I ORDERED A UV PHOTOTHERAPY LAMP FROM (B)(6). I TRIED IT TWICE, THE FIRST TIME IT BURNED TERRIBLY BUT I THOUGHT IT MIGHT BE HELPING BUT COULDN'T HANDLE THE BURN SO I STOPPED IT. TODAY I PUT IT ON AGAIN IT BURNED AND SPREAD, MY SKIN IS THE WORSE ITS EVER BEEN NOW. THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE AND SHOULD NOT BE AVAILABLE ON (B)(6) WITHOUT PRESCRIPTION. OTHERWISE, PATIENTS WILL GET BURNED LIKE ME. FDA SAFETY REPORT ID# (B)(4).