MAUDE Adverse Event Report: CLAREBEND, INC. SKIN CLASSIC; EPILATOR, HIGH FREQUENCY, NEEDLE TYPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Scarring (2061); Burn, Thermal (2530)

Event Date 12/21/2019

Event Type  Injury  

Event Description

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).

• Brand Name: SKIN CLASSIC
• Type of Device: EPILATOR, HIGH FREQUENCY, NEEDLE TYPE
• Manufacturer (Section D): CLAREBEND, INC.
• MDR Report Key: 9641798
• MDR Text Key: 177030004
• Report Number: MW5092595
• Device Sequence Number: 1
• Product Code: KCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 60