MAUDE Adverse Event Report: ANGEL KISS LLC ANGEL KISS PORTABLE UV PHOTOTHERAPY LAMP; LIGHT, ULTRAVIOLET, DERMATOLOGICAL

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2021

Event Type  Injury  

Event Description

I'm a psoriasis patient, i bought a uv phototherapy light on (b)(4), but the user manual is badly written in english, i could not understand it, and i didn't know how to use it, after consulting the doctor i knew it was a prescription product, i should get doctor rx first to purchase it, so i returned it and got a refund.The product code is ftc, if people can buy it directly online, the lamp will burn people badly if not operating well, this is violating fda regulation and laws, i hope you can help to remove this listing on (b)(4).(b)(4).

• Brand Name: ANGEL KISS PORTABLE UV PHOTOTHERAPY LAMP
• Type of Device: LIGHT, ULTRAVIOLET, DERMATOLOGICAL
• Manufacturer (Section D): ANGEL KISS LLC
• MDR Report Key: 11207543
• MDR Text Key: 228454297
• Report Number: MW5098926
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): Y
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 35 YR
• Patient Weight: 72