MAUDE Adverse Event Report: YONKER UVB PHOTOTHERAPY INSTRUMENT. ; XUZHOU YONGKANG ELECTRONIC SCIENCE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 06/10/2017

Event Type  Injury  

Event Description

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.

• Brand Name: YONKER UVB PHOTOTHERAPY INSTRUMENT.
• Type of Device: XUZHOU YONGKANG ELECTRONIC SCIENCE
• MDR Report Key: 6642914
• MDR Text Key: 77741414
• Report Number: MW5070412
• Device Sequence Number: 1
• Product Code: FTC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 27 YR
• Patient Weight: 61