inforMED
MalfunctionFTC

YONKER UVB PHOTOTHERAPY INSTRUMENT

Received Sep 23, 2019 · Event occurred Jun 10, 2017

Report 3013482554-2019-00006 · MDR key 9106821

Device

Generic name

Light, Ultraviolet, Dermatological

Manufacturer

Yonker Medical

Model number

YK-6000BT

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Burn(s)
  • Burn(s)

Narrative

Description of Event or Problem

I BROUGHT THE DEVICE "YONKER UVB-NARROWBAND-LAMP-311NM-PHOTOTHERAPY" ON (B)(6), AND FOUND IT HAS NO INSTRUCTION ON HOW TO USE IT. THEN I USED IT FOR 3 MINUTES ON MY ARM AND MY ARM GOT BURNED. I CHECKED THE DEVICE AND IT WAS MADE-IN-(B)(4) AND I CAN'T FIND ANY INFORMATION ON THE FDA WEBSITE. I SUSPECT IT IS A NON-FDA APPROVED PRODUCT THAT CAN CAUSE SERIOUS BURN TO THE BODY. FREQUENCY: TWICE A DAY. HOW WAS IT TAKEN OR USED: TOPICAL. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2017. DID THE PROBLEM STOP AFTER THE PRODUCT REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES. DID THE PRODUCT RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES. WHY WAS THE PERSON USING THE PRODUCT: I HAVE VITILIGO ON MY LEFT ARM.

Remedial action

  • Relabeling
  • Other