BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OREETH IPL HAIR REMOVAL DEVICE

    MDR report key: 24616958 · Received March 17, 2026

    Report

    Report Number
    MW5185280
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    DONGGUAN LIDE ELECTRIC APPLIANCE CO., LTD.
    Product Code
    OHT
    UDI-DI
    06976971650091
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A HAIR REMOVAL DEVICE (OREETH TM002) FROM AMAZON (SELLER: CHAIBIZ) FOR PERSONAL COSMETIC USE. DURING THE SECOND NORMAL USE, THE DEVICE SUDDENLY OVERHEATED, BECAME EXTREMELY HOT, AND CAUSED SERIOUS BURNS ON MY LEGS. THE DEVICE WAS USED EXACTLY ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. IMMEDIATE EFFECTS INCLUDED PAIN, REDNESS, AND SKIN DAMAGE. MEDICAL EXAMINATION INDICATED THAT THE BURN MAY LEAVE PERMANENT SCARS. ACCORDING TO THE OREETH TM002 USER MANUAL (MANUALS.PLUS), UNDER TROUBLESHOOTING: "DEVICE FEELS HOT DURING USE -- USE COOLING MODE; TAKE BREAKS BETWEEN SESSIONS." "BURNING SMELL DURING USE -- STOP USE AND INSPECT THE DEVICE." HOWEVER, THE MANUAL DOES NOT INCLUDE EXPLICIT WARNINGS ABOUT SEVERE BURNS OR PERMANENT SCARS, INDICATING INSUFFICIENT RISK WARNING. SOURCE: MANUALS. PLUS OREETH TM002 USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433490 OREETH IPL HAIR REMOVAL DEVICE LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL OHT DONGGUAN LIDE ELECTRIC APPLIANCE CO., LTD. TM002 06976971650091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R| O