MAUDE Adverse Event Report: YONKER MEDICAL UV PHOTOTHERAPY INSTRUMENT; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

Model Number UVB DIGITAL DISPLAY

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/17/2019

Event Type  malfunction  

Event Description

I purchased a uv phototherapy device for the treatment of psoriasis.The instructions are very poor.Like a mix of chinese and english.After looking around in the internet, i learned that i should have been asked for a prescription before being allowed to purchase this product.This is not a over the counter device.I am afraid to use it because some instructions indicate that you should increase the treatment time if you are getting a sunburn.This does not sound right.I think the fda needs to be aware of this.Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY INSTRUMENT
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): YONKER MEDICAL
• MDR Report Key: 8631760
• MDR Text Key: 145934550
• Report Number: MW5086799
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• 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: 05/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2020
• Device Model Number: UVB DIGITAL DISPLAY
• Device Catalogue Number: YK8000BT
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR