MAUDE Adverse Event Report: BLUE SCITECH CO., LTD. UV PHOTOTHERAPY DEVICE; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

Model Number BU-10

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

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

Event Date 08/05/2019

Event Type  malfunction  

Event Description

The product is a hand held uvb wand class ii medical device.Prescription required.Purchased to use for treatment of psoriasis.Purchased off (b)(6).Unit came from china.Illustrations in the instructions are black and white and are of so low resolution you cannot see.One picture is of the skin and you are instructed to look at the color but the picture is black and white.The instructions were translated poorly and it is hard trying to figure out how to use the device.The specification states that the uvb lamp intensity is between 3.2 and 7.2.There is a record in the manual that shows this unit tested at 10.0 intensity.Way too high.Instruction states that user must read both manuals but only one was shipped.The instructions tell me to go to the hosp 24 hours after treating myself the 1st time but does not say why.The unit came with a european style plug and with a very poor adapter.I know that the usa products require the proper ac plug.Everything seems wrong with this device.There is no quality.Someone may get hurt if they try to use the device.Fda safety report id# (b)(4).

• Brand Name: UV PHOTOTHERAPY DEVICE
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): BLUE SCITECH CO., LTD.
• MDR Report Key: 8869140
• MDR Text Key: 153959572
• Report Number: MW5088849
• 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: 08/05/2019

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: BU-10
• Device Catalogue Number: NONE
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 170