UV PHOTOTHERAPY
Received Jan 25, 2021 · Event occurred Jan 19, 2021
Report MW5099002 · MDR key 11229228
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
UnkProduct problems
- Use of Device Problem
- Patient-Device Incompatibility
Patient
Not reported
- Skin Irritation
- Burn, Thermal
- Skin Irritation
- Burn, Thermal
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 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). .