YONKER UVB PHOTOTHERAPY INSTRUMENT.
Received Jun 14, 2017 · Event occurred Jun 10, 2017
Report MW5070412 · MDR key 6642914
Device
Generic name
Xuzhou Yongkang Electronic Science
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
27 YR
- Burn, Thermal
- Burn, Thermal
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.