BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECRET RF

    MDR report key: 23835104 · Received December 17, 2025

    Report

    Report Number
    3010363436-2025-00001
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    March 30, 2024
    Report Date
    December 18, 2025
    Manufacturer
    CLASSYS INC
    Product Code
    GEI
    UDI-DI
    08800023200171
    PMA / PMN Number
    K170325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED FOLLOWING PATIENT'S COMPLAINT TO FDA (#MW5178360). THE PATIENT INCORRECTLY LISTED THE MANUFACTURER AS CUTERRA, THE DISTRIBUTOR, ON REPORT MW5178360, AND CUTERRA PROVIDED US WITH THE REPORTING INFORMATION ON NOVEMBER 22, 2025. THE PATIENT UNDERWENT A MICRONEEDLING TREATMENT USING THE SECRET RF DEVICE AT CLINIC-A ON (B)(6) 2024. ACCORDING TO THE TREATING CLINIC, POST-TREATMENT ASSESSMENT REVEALED NO OBSERVED SIGNS OF FAT LOSS, FACIAL DISFIGUREMENT, BRUISING, CONTUSION, OR DEFORMITY. THE PATIENT LATER REPORTED THAT SHE SOUGHT TREATMENT AT ANOTHER CLINIC-B AND UNDERWENT A FAT TRANSFER PROCEDURE IN (B)(6) 2025, APPROXIMATELY ONE YEAR AFTER THE SECRET RF TREATMENT. BASED ON THE PROCEDURE REPORT PROVIDED BY THE PATIENT, THE PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS AT CLINIC-B WAS DOCUMENTED AS "COSMESIS," INDICATING THAT THE PROCEDURE WAS PERFORMED SOLELY FOR AESTHETIC PURPOSES, WITHOUT AN UNDERLYING PATHOLOGICAL CONDITION. THE PROCEDURE REPORT DOES NOT REFERENCE ALLEGED FAT LOSS, FACIAL DISFIGUREMENT, OR DEFORMITY AS THE INDICATION FOR TREATMENT. THE PATIENT WAS PRESENTED WITH AVAILABLE TREATMENT OPTIONS AND ELECTED TO PROCEED WITH FAT TRANSFER. WE CONFIRMED WITH DISTRIBUTOR THAT THERE WAS NO DEVICE MALFUNCTION, ERROR MESSAGE, OR ABNORMAL PERFORMANCE WAS REPORTED FROM THE USER FACILITY AT THE TIME OF THE SECRET RF TREATMENT, (B)(6) 2024. A REVIEW OF THE MANUFACTURING RECORDS AND INSPECTION RESULTS FOR THE SECRET RF DEVICE USED DURING THE PROCEDURE (SERIAL NUMBER: (B)(6) AND THE ASSOCIATED 25-PIN NON-INSULATED TIP CONFIRMED THAT THE DEVICE MET ALL APPLICABLE SPECIFICATIONS, WITH NO NONCONFORMITIES IDENTIFIED. AND NO SIMILAR COMPLAINTS OR ADVERSE EVENTS WERE REPORTED FOR OTHER DEVICES DISTRIBUTED DURING THE SAME TIME PERIOD. BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT HAS BEEN IDENTIFIED. WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS AND WILL REASSESS IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THIS REPORT IS SUBMITTED FOLLOWING PATIENT'S REPORT TO FDA MW5178360, CLAIMING "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." 1.5 YEAR POST SECRET RF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230421 SECRET RF MICRO-NEEDLE FRACTIONAL RF GEI CLASSYS INC MTR-C1 08800023200171

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other