BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECRET RF

    MDR report key: 24553996 · Received March 9, 2026

    Report

    Report Number
    3010363436-2026-00001
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    March 8, 2023
    Report Date
    February 19, 2026
    Manufacturer
    CLASSYS INC
    Product Code
    GEI
    UDI-DI
    08800023200171
    PMA / PMN Number
    K170325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED FOLLOWING A PATIENT'S COMPLAINT TO THE FDA (# MW5182187). THE PATIENT INCORRECTLY LISTED THE MANUFACTURER AS CUTERA, THE DISTRIBUTOR, ON REPORT MW5182187, AND CUTERA PROVIDED US WITH THE REPORTING INFORMATION ON FEBRUARY 11, 2026. AN UNKNOWN 47-YEAR-OLD HISPANIC FEMALE SUBMITTED A VOLUNTARY MDR TO THE FDA (MDR NO. MW5182187) ON (B)(6) 2026 . THE PATIENT REPORTED THAT THE TREATMENT OCCURRED ON (B)(6) 2023 AND IDENTIFIED THE DEVICE AS SECRET RF, STATING SHE RECEIVED A SECRET RADIOFREQUENCY TREATMENT. SHE INDICATED THAT SHE UNDERWENT A TOTAL OF THREE TREATMENTS IN 2023. THE PATIENT DID NOT PROVIDE HER NAME, ADDRESS, OR ANY OTHER IDENTIFYING OR CONTACT INFORMATION. SHE ALSO DID NOT IDENTIFY THE FACILITY WHERE THE TREATMENT WAS PERFORMED OR PROVIDE ANY CLINIC CONTACT DETAILS. AS A RESULT, WE ARE UNABLE TO FURTHER INVESTIGATE THE REPORTED EVENT, AS BOTH THE PATIENT AND THE TREATING CLINIC ARE UNKNOWN TO DISTRIBUTOR AND MANUFACTURER, AND NO CONTACT INFORMATION IS AVAILABLE TO OBTAIN ADDITIONAL DETAILS. ACCORDING TO THE DISTRIBUTOR'S REVIEW OF CLINICAL INCIDENT REPORTS FOR THE SECRET PRODUCT FAMILY FROM 2022 TO THE PRESENT, THERE IS NO IDENTIFIED REPORT THAT CORRELATE WITH THE REPORTED TIMING, GEOGRAPHIC LOCATION (UNITED STATES), OR THE CLINICAL SIGNS AND SYMPTOMS DESCRIBED BY THE PATIENT. BASED ON THE AVAILABLE INFORMATION, THIS APPEARS TO BE THE FIRST NOTIFICATION OF THE ALLEGED CLINICAL EVENT. WE WILL CONTINUE TO MONITOR FUTURE CLINICAL EVENT REPORTS ASSOCIATED WITH THE SECRET PRODUCT FAMILY FOR ANY SIMILAR FINDINGS. IF ADDITIONAL INFORMATION SPECIFIC TO THIS CASE BECOMES AVAILABLE, WE WILL CONDUCT AN APPROPRIATE INVESTIGATION.

    Description of Event or Problem · 0

    THIS REPORT IS SUBMITTED FOLLOWING PATIENT'S REPORT TO FDA MW5182187. THE PATIENT REPORTED THAT THE TREATMENT OCCURRED ON (B)(6) 2023 AND IDENTIFIED THE DEVICE AS SECRET RF, STATING SHE RECEIVED A SECRET RADIOFREQUENCY TREATMENT THREE TIMES. THE THIRD SECRET RF TREATMENT WAS MUCH MORE PAINFUL AND CAUSED PROLONGED TEARING. AFTER THE SWELLING WENT DOWN, CHEEKS LOOKED FLAT AND THE AREA UNDER EYES APPEARED SUNKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614770 SECRET RF MICRO-NEEDLE FRACTIONAL RF GEI CLASSYS INC MTR-C1 08800023200171

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other