inforMED
InjuryFTC

UV PHOTOTHERAPY LAMP

Received Jan 28, 2021 · Event occurred Jan 15, 2021

Report MW5099086 · MDR key 11250939

Device

Generic name

Light, Ultraviolet, Dermatological

Model number

KN-4003BL

Product problems

  • Improper or Incorrect Procedure or Method

Patient

Not reported

  • Radiation Burn
  • Radiation Burn

Narrative

Description of Event or Problem

I BOUGHT A UV LAMP FROM THE LINK WWW.AMAZON.COM/DP/B06XCGGJ7C TO TREAT MY PSORIASIS. I USED THIS LAMP ON MY FACE AND THEN 30 SECONDS GO BY AND MY FACE FELT LIKE IT WAS BURNING OFF, EVEN AFTER WASHING MY FACE I COULDN'T GET IT TO STOP BURNING. THIS DEVICE IS A PRESCRIPTION (RX) MEDICAL DEVICE WHICH SHOWS IN ITS PACKAGE AND MANUAL. IT IS ILLEGAL TO SELL THIS PSORIASIS LAMP ONLINE WITHOUT DOCTOR'S PRESCRIPTION ACCORDING TO FDA REGULATIONS. IT WILL CAUSE SEVERE BURNING TO PEOPLE IF THEY DO NOT USE THIS PSORIASIS LAMP UNDER THE DIRECTION OF A LICENSED PHYSICIAN. FDA SHOULD REMOVE THIS DEVICE FROM (B)(6). FDA SAFETY REPORT ID #: (B)(4).

Description of Event or Problem

ADDITIONAL INFO RECEIVED FROM REPORTER ON 04-FEB-2021 FOR MW5099086: THE REPORTER HAS ADDED PATIENT INFORMATION, A MODEL NUMBER, AND THE OPERATOR OF THE DEVICE . FDA SAFETY REPORT ID # (B)(4).