BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECRET RF

    MDR report key: 23437064 · Received October 31, 2025

    Report

    Report Number
    MW5178360
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    March 30, 2024
    Report Date
    October 27, 2025
    Manufacturer
    CUTERA, INC.
    Product Code
    OUH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RF MICRONEEDLING SECRET RF AT A DEPTH OF 2 MM ON CHEEKS. IT WAS RECOMMENDED TO ME BC I HAD A SCRATCH ON MY NOSE (32 YRS OLD) LEFT ME WITH FAT LOSS AND FACIAL DISFIGUREMENT. THOUSANDS OF DOLLARS IN TREATMENT TO CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893989 SECRET RF SKIN RESURFACING RF APPLICATOR OUH CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other