BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECRET RF

    MDR report key: 9622988 · Received January 22, 2020

    Report

    Report Number
    MW5092462
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    June 19, 2018
    Report Date
    January 21, 2020
    Manufacturer
    UNKNOWN
    Product Code
    OUH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD RF MICRONEEDLING TREATMENT TO CHEEKS/FACE USING SECRET RF PRODUCT APPLIED BY (B)(6). I HAD SIGNIFICANT REDNESS FOLLOWED BY EXTENSIVE PEELING, SIMILAR TO A SEVERE SUNBURN. I BELIEVE THE BURNS WERE DUE TO TOO MUCH RF RADIATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82274 SECRET RF SKIN RESURFACING RF APPLICATOR-SECRET RF OUH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other