MAUDE Adverse Event Report: VIOL CO.,LTD SYLFIRM X; RADIO FREQUENCY SYSTEM

Model Number	SYLFIRM X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is a follow-up report from the manufacturer regarding mw5182490.Patient report details: the patient claims fat loss and scarring on her face and neck after receiving sylfirm x.The patient claims her skin became so thin that pulses could be seen under the skin over her trachea.She also claims that this treatment reversed the effects of another dermatological procedure she received two years prior.Investigation results: customer complaints: after reviewing customer feedback collected by viol co., ltd, we have not identified any customer complaints related to fat reduction with sylfirm x.However, the fda has received three reports of patients claiming fat reduction.In one of these cases, the submitted information was deemed unreliable upon review.In the remaining two cases, the investigation was halted due to failure to contact the patient for additional information to determine the cause, or failure to cooperate with recommendations to visit a healthcare provider for further evaluation.Therefore, in all three cases, the facts and causes of fat reduction have not been fully confirmed.To date, no customer complaints related to fat reduction with sylfirm x have been identified among the customer feedback received by the manufacturer.Key doctor advice: despite the results of the customer feedback investigation, we sought clinical advice from a domestic doctor regarding the possibility that sylfirm x may have contributed to the fat reduction.However, we have not yet received a response to our inquiry.We will compile the information and provide a further report once the investigation is complete.Treatment conditions: we requested the patient's hospital information to compare the current report with the doctor's advice.However, we have not yet received any contact.Therefore, it is impossible to confirm the exact conditions under which the patient underwent the procedure.Conclusion: to date, no customer complaints have been received that resemble the patient's claims of fat loss due to the sylfirm x procedure.We are seeking clinical advice from domestic physicians regarding the possibility that fat loss may be attributed to the sylfirm x procedure, and we have requested the patient's hospital information to confirm the procedure's requirements.However, we have not yet received a response from the physician or patient.Once the investigation is complete, we will provide a supplementary report comparing the patient's treatment requirements with the physician's advice.

• Brand Name: SYLFIRM X
• Common Device Name: RADIO FREQUENCY SYSTEM
• Manufacturer (Section D): VIOL CO.,LTD; 608, 609, 808, 809, bundang; technopark c, 744 pangyo-ro; bundang-gu, seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer (Section G): VIOL CO.,LTD; 608, 609, 808, 809, bundang te; 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer Contact: minyoung park ; 608, 609, 808, 809, bundang technopark c; 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• MDR Report Key: 24554446
• Report Number: 3009206941-2026-00001
• Device Sequence Number: 15660481
• Product Code: GEI
• UDI-Device Identifier: 08809502330101
• UDI-Public: 08809502330101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K213612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SYLFIRM X
• Device Catalogue Number: SYLFIRM X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 57 KG