MAUDE Adverse Event Report: YONKER MEDICAL YONKER PHOTOTHERAPY; UV RADIATION TREATMENT SYSTEM

Model Number YK-6000BT

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Event Description

The unit is a uvb lamp used to treat psoriasis or vitiligo.Class ii medical device that requires prescription to purchase.The instructions state that if you receive a mild burn or itch on the skin, increase the treatment time.This is a huge error and will lead to serious burns if purchased by people who do not understand phototherapy.Other errors: unit is not 510k cleared as required.I asked the company about this but they said they do not have 510k.A prescription is required to purchase.I was not asked to submit a prescription.Anybody can buy this through (b)(6).The product comes from (b)(4) but there is no mention of that fact.Labeling does not include instructions as to how to program the timer.There is no mention of who the manufacturer was or contact information.There is no udi label on the box or the device.There are no warnings, cautions or precautions on box.There is nothing on the box that requires a doctor's prescription.Very clear that a usability study was not performed.There are no statements on the box warning of uv radiation.Translation is profanity.Very difficult to figure out what instructions are trying to tell you.Unit does not work.They sent 220 unit power supply.They have not responded to my request for support.Radiation intensity chart has values expressed in mw/cm km2.What is that? there is a lot wrong with this device but it will cause serious burns if you follow the instructions as stated in the manual.Fda safety report id #: (b)(4).

• Brand Name: YONKER PHOTOTHERAPY
• Type of Device: UV RADIATION TREATMENT SYSTEM
• Manufacturer (Section D): YONKER MEDICAL; xuzhou, 22100 0; CH 221000
• Manufacturer Contact: xiao wan ; xuzhou, jiangsu ; CH
• MDR Report Key: 8826691
• MDR Text Key: 203311773
• Report Number: 3013482554-2019-00001
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Remedial Action: Relabeling
• Type of Report: Initial
• Report Date: 08/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: YK-6000BT
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other