inforMED
InjuryKCW

SKIN CLASSIC

Received Feb 12, 2020 · Event occurred Dec 20, 2019

Report MW5092983 · MDR key 9706617

Device

Generic name

Epilator High Frequency Needle-type

Manufacturer

Clareblend, Inc.

Product problems

  • Patient-Device Incompatibility

Patient

17 YR

  • Pain
  • Scarring
  • Burn, Thermal
  • Pain
  • Scarring
  • Burn, Thermal

Narrative

Description of Event or Problem

WHILE GETTING A FACIAL MY DAUGHTER WAS OFFERED A "NEW" TREATMENT FOR HER BLACK/HEADS ON HER CHIN. THE TREATMENT BURNT ALL THE PORES ON HER CHIN CAUSING SEVERE PAIN, SCARRING AND ICE PICK DEEP SCARS. BURNED CHIN SCARING PAIN. "RNFACES". FDA SAFETY REPORT ID# (B)(4).