BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN CLASSIC

    MDR report key: 9641798 · Received January 28, 2020

    Report

    Report Number
    MW5092595
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    December 21, 2019
    Report Date
    January 26, 2020
    Manufacturer
    CLAREBEND, INC.
    Product Code
    KCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103173 SKIN CLASSIC EPILATOR, HIGH FREQUENCY, NEEDLE TYPE KCW CLAREBEND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other