inforMED
InjuryFTC

UV PHOTOTHERAPY LAMP

Received Jan 29, 2021 · Event occurred Jan 19, 2021

Report MW5099124 · MDR key 11261771

Device

Generic name

Light, Ultraviolet, Dermatological

Manufacturer

Unk

Product problems

  • Patient-Device Incompatibility

Patient

Not reported

  • Burn(s)
  • Skin Irritation
  • Burn(s)
  • Skin Irritation

Narrative

Description of Event or Problem

I BOUGHT A UV PHOTOTHERAPY LAMP FROM (B)(6) A FEW DAYS AGO. THE ITEM LINK IS (B)(6). MY SKIN WAS BURNED AND GOT WORSE AFTER APPLYING THIS. TRIED AGAIN THE NEXT DAY TO SEE IF MAYBE IT WAS JUST A FLUKE, BURNED EVEN WORSE AND IRRITATED THE SKIN MORE THAN IT ALREADY WAS. MY DERMATOLOGIST SAYS FDA RESTRICTS THIS PSORIASIS LAMP TO SELL WITHOUT THE ORDER OF A PHYSICIAN. ITS PACKAGE ALSO PROVES THIS. ITS 510K NUMBER IS K132643 WHICH CLEARLY SHOWS THAT THIS IS A PRESCRIPTION (RX) MEDICAL DEVICE. WHY FDA ALLOWS THIS RX PRODUCT SOLD ON (B)(6)? I THINK FDA MUST REQUIRE (B)(6) TO REMOVE THIS ITEM. (B)(6). FDA SAFETY REPORT ID # (B)(4).