BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOUNIYA LASER HAIR REMOVAL DEVICE

    MDR report key: 22328990 · Received June 24, 2025

    Report

    Report Number
    MW5171877
    Event Type
    Injury
    Date Received
    June 24, 2025
    Report Date
    June 12, 2025
    Manufacturer
    MILEY TECHNOLOGY (HEBEI) CO. LTD
    Product Code
    OHT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TRIED AND FAILED (B)(4); REPORTED BY HCP. DID NOT CONSENT TO FOLLOW UP, ALL AVAILABLE INFORMATION IS PROVIDED IN THIS REPORT NO FURTHER CLARIFICATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873386 IOUNIYA LASER HAIR REMOVAL DEVICE LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL OHT MILEY TECHNOLOGY (HEBEI) CO. LTD MLY-T069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown