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

Model Number OKY-6000B

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 08/20/2020

Event Type  Injury  

Event Description

I bought a uvb handheld wand for the treatment of psoriasis.I noticed a problem right away because the manual is in "chinklish".There was no official translation into english and it is impossible to understand how to use the device safely.I later learned that i should have been asked for a doctors prescription because this is a dangerous device to use with out being properly diagnosed by a dermatologist.The web site even states no prescription required.The instructions instruct me to determine a safe dosage but there is no explanation as to how to do that.The manual later states that you have to see a doctor and go through special testing to figure out a safe dose.Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY INSTRUMENT
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• MDR Report Key: 10454293
• MDR Text Key: 204626047
• Report Number: MW5096288
• 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: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: OKY-6000B
• Device Catalogue Number: Y-3VT
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 79