MAUDE Adverse Event Report: LED FACE MASK; MASK, SCAVENGING

Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inadequate Instructions for Non-Healthcare Professional (2956)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As a former regulatory professional, i'm very aware of labeling requirements for both class iii and 510k cleared devices.I recently ordered from (b)(6) a led face mask device.The advertisement on (b)(6), the distributor, is called "fda cleared led facial skin care mask light treatment led facial mask led face mask light therapy with red light therapy and face and neck".I ordered it on (b)(6) 2022, it was received on (b)(6) 2022.I did not inspect the device till yesterday, (b)(6) 2022, because it was a birthday present.The information did not mention contraindications, i.E., thyroid disease.The date of return was closed ((b)(6) 2022) although i thought i had 60 days.Upon inspection of the 510k device, the labeling is clearing deficient.There is no labeling that identifies it as a 510k cleared device.No lot numbers, no name of manufacturer, no expiration dates.Instructions were almost unreadable, written by someone whose first language is not english, likely (b)(6).And the contraindications paragraph called "prohibit the use of crowd" states, "pregnant women, children and thyroid disease" are not to use the device.This should have been written in the description of the device on (b)(6).The labeling requirements are not fda bona fides.Name of the company that makes (or compounds) the product: (b)(4).I never used the device.Instructions weren't clear.

• Brand Name: LED FACE MASK
• Common Device Name: MASK, SCAVENGING
• MDR Report Key: 14495295
• Report Number: MW5109905
• Device Sequence Number: 13419353
• Product Code: KHA
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/21/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2022
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White