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

Model Number BU-10

Device Problems Energy Output Problem (1431); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 08/05/2019

Event Type  Injury  

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 intensity of the included lamp should be 3.2 to 7.2 mw/cm2.A test report, included in the manual, states that this lamp testes to be 10.0 mw/cm2.This figure is way above the stated specification for the device.The manual states that there are two manuals included with the device.The 1st manual states that the second manual must be read in order to calculate the treatment time.The 2nd manual was not included.The unit came with a two prong european style round prong plug.A very poor quality adapter was included which does not work all the time.A prescription is required to purchase this device in the usa.During the order process there was no mention of a prescription.

• Brand Name: UV PHOTOTHERAPY DEVICE
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): BLUE SCI TECH CO., LTD
• MDR Report Key: 8906200
• MDR Text Key: 154944508
• Report Number: MW5089106
• 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: Unknown
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BU-10
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 170