inforMED
InjuryOHT

OREETH IPL HAIR REMOVAL DEVICE

Received Mar 17, 2026 · Event occurred Feb 10, 2026

Report MW5185280 · MDR key 24616958

Device

Generic name

Light Based Over-the-counter Hair Removal

Model number

TM002

Patient

NA · Unknown

  • Erythema
  • Pain
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

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.