MAUDE Adverse Event Report: UNKNOWN DOSET FACIAL MASSAGER RED-LIGHT-THERAPY-FOR-FACE AND NECK, SCULPTING WAND; OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE

Medical Device Problem Codes	Product Quality Problem (1506); Inappropriate/Inadequate Shock/Stimulation (1574); Device Markings/Labelling Problem (2911); Protective Measures Problem (3015)
Health Effect - Clinical Codes	Erythema (1840); Discomfort (2330); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
I'm reaching out to report a serious concern about a 7-color led facial device i bought from amazon platform.Brand: doset facial massager red-light-therapy-for-face and neck, face sculpting wand with 7 color asin: (b)(6) after trying it a few times, i noticed: slight electric shock sensation during use, especially near the metal parts.Very strong and uneven light, it caused eye discomfort and skin redness.The material feels cheap, and i even got some skin irritation after using it.There's no fda approval or safety label anywhere on the device or in the packaging.This product doesn't seem safe to use on the face or neck, and i'm really worried it could harm others too.Please check if this item meets basic safety standards.I would like to know: if the seller can show any official safety or fda certification; if i can get a refund; and if this item will be removed or reviewed.

• Brand Name: DOSET FACIAL MASSAGER RED-LIGHT-THERAPY-FOR-FACE AND NECK, SCULPTING WAND
• Common Device Name: OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 22576873
• Report Number: MW5173130
• Device Sequence Number: 4362181
• Product Code: OLP
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian