MAUDE Adverse Event Report: YONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENC UV / PHOTOTHERAPY; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

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 05/17/2019

Event Type  malfunction  

Event Description

I just received a uvb wand and the instructions are in (b)(6)/english.I do not know where to start.I found out that the unit requires a prescription from my dr.No one said that, my friend says do not use it.There is an instruction that says if i get burned, increase treatment time and i am not sure about that.Fda safety report id# (b)(4).

• Brand Name: UV / PHOTOTHERAPY
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): YONKER MEDICAL / XUZHOU YONGKANG ELECTRONIC SCIENC; xuzhou 22100 0; CH 221000
• Manufacturer Contact: xiao wan ; xuzhou, jiangsu 22100-0 ; CH 221000
• MDR Report Key: 8890818
• MDR Text Key: 216644770
• Report Number: 3013482554-2019-00002
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: YK-6000BT
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention