InjuryKCW
SKIN CLASSIC
Received Jan 28, 2020 · Event occurred Dec 21, 2019
Report MW5092595 · MDR key 9641798
Device
Generic name
Epilator, High Frequency, Needle Type
Manufacturer
Clarebend, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
17 YR
- Pain
- Scarring
- Burn, Thermal
- Pain
- Scarring
- Burn, Thermal
Narrative
Description of Event or Problem
MY DAUGHTER WENT FOR A REGULAR FACIAL. THE FACIALIST PERFORMED A 'NEW TREATMENT' ON HER WITH A MACHINE CALLED SKIN CLASSIC. IT WAS PAINFUL AND LEFT HER WITH PITTED SCARS AND BURN MARKS ON HER ENTIRE CHIN. WE VISITED BOTH A DERMATOLOGIST WHOM SHE SEES REGULARLY AND AFTER THAT A PLASTIC SURGEON. THEY BOTH WERE SHOCKED AT THE DAMAGE THAT WAS DONE TO MY DAUGHTER'S CHIN. SHE WILL NOW NEED LASER TREATMENT AT LEAST 6 ROUNDS AND BOTH DRS FELT IT WOULD NEVER ACTUALLY BE RIGHT. FDA SAFETY REPORT ID# (B)(4).