BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN CLASSIC

    MDR report key: 9706617 · Received February 12, 2020

    Report

    Report Number
    MW5092983
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 9, 2020
    Manufacturer
    CLAREBLEND, 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

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166878 SKIN CLASSIC EPILATOR HIGH FREQUENCY NEEDLE-TYPE KCW CLAREBLEND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other