PSORIASIS UV PHOTOTHERAPY LAMP
Received Jan 22, 2021 · Event occurred Jan 16, 2021
Report MW5098977 · MDR key 11222802
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
UnkProduct problems
- Product Quality Problem
Patient
36 YR
- Burning Sensation
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Burning Sensation
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
(B)(6). I BOUGHT A UV PHOTOTHERAPY LAMP FROM THIS LINK FROM (B)(6). I HAD TO SEE A DOCTOR THE DAY AFTER ISSUING BECAUSE MY SKIN GOT WAY WORSE WITH INTENSE BURNING AND ICKYNESS IT BURNED MY ALL SKIN ON LEGS AND HANDS. MY DOCTOR TOLD ME THIS LAMP IS AN RX MEDICAL DEVICE AND NEED TO BE USED WITH PRESCRIPTION FROM DOCTOR. SO, IT IS ILLEGAL TO SELL THIS LAMP ON (B)(6) WITHOUT PRESCRIPTION. I CONTACTED (B)(6) AND REQUIRE THEM TO REMOVE THIS LAMP FROM ITS WEBSITE BUT NOTHING HAPPENED. I HAVE TO REPORT THIS TO FDA AND HOPE THAT FDA WILL PUSH ACTION ON (B)(6) TO REMOVE IT TO AVOID MORE BURN AND HURT FROM THIS LAMP. FDA SAFETY REPORT ID # (B)(4).