UV PHOTOTHERAPY LAMP
Received Feb 3, 2021 · Event occurred Jan 19, 2021
Report MW5099211 · MDR key 11278727
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
Angel Kiss Llc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Radiation Burn
- Skin Irritation
- Radiation Burn
- Skin Irritation
Narrative
Description of Event or Problem
MY SKIN WAS BURNED; I BOUGHT A UV PHOTOTHERAPY LAMP FROM (B)(6) A FEWS 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. FDA SAFETY REPORT ID# (B)(4).