BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOSET FACIAL MASSAGER RED-LIGHT-THERAPY-FOR-FACE AND NECK, SCULPTING WAND

    MDR report key: 22576873 · Received July 23, 2025

    Report

    Report Number
    MW5173130
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    July 18, 2025
    Report Date
    July 19, 2025
    Manufacturer
    UNKNOWN
    Product Code
    OLP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1591001 DOSET FACIAL MASSAGER RED-LIGHT-THERAPY-FOR-FACE AND NECK, SCULPTING WAND OVER-THE-COUNTER POWERED LIGHT BASED LASER FOR ACNE OLP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Disability| R