inforMED
InjuryFTC

UV PHOTOTHERAPY

Received Jan 27, 2021 · Event occurred Jan 22, 2021

Report MW5099073 · MDR key 11243801

Device

Generic name

Light, Ultraviolet, Dermatological

Manufacturer

Unk

Product problems

  • Use of Device Problem
  • Patient-Device Incompatibility

Patient

Not reported

  • Itching Sensation
  • Rash
  • Burning Sensation
  • Burn, Thermal
  • Itching Sensation
  • Rash
  • Burning Sensation
  • Burn, Thermal

Narrative

Description of Event or Problem

BURNED MY PALM AND FINGER; MY HUSBAND BOUGHT ME THIS LAMP BECAUSE I HAD ECZEMA DYSHIDROTIC ON MY PALM AND AROUND MY FINGERS. THIS LAMP DIDN'T HELP AT ALL. I WAS STILL ITCHING, BURNING AND SKIN WAS BREAKING OUT NONSTOP. I ONLY USED IT FOR 3 DAYS AND GAVE UP BECAUSE I FELT LIKE IT WASN'T SPEEDING UP THE PROCESS OR HELPING ME HEAL. THE LINK IS HERE (B)(6). ITS 510K NUMBER IS K132643 WHICH CLEARLY SHOWS THAT THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE. (B)(6) WILL BE PUNISHED IF (B)(6) DON'T TAKE THIS CASE SERIOUS TO REMOVE IT; (B)(6). FDA SAFETY REPORT ID# (B)(4).