MAUDE Adverse Event Report: VIOL CO.,LTD. SYLFIRM X

Model Number	SYLFIRM X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further investigation is ongoing and we expect to report back on our findings within one month at the latest.
Event or Problem Description
Based on the information investigated so far, it is difficult to confirm whether the side effects claimed by the patient were caused by sylfirm x, so further investigation is necessary.The results of the investigation so far are as follows.1.Based on the medwatch(mw5167590) content (contacted via viol's representative email) reported by the patient, neither viol nor viol's distributor, (b)(6), have received emails with such content.2.The patient received a total of 4 times sylfirm x treatments from (b)(6) 2023 to (b)(6) 2024, and the conditions for the 1st to 3rd treatments were all the same.Therefore, if these side effects occurred due to the sylfirm x treatment, the side effects should have occurred from the 1st treatment.However, the patient received three additional treatments after that, which suggests that the side effects did not occur in the 1st to 3rd treatments.However, since information on the 4th procedure has not been collected yet and only the before photo was provided by the hospital, it is necessary to confirm whether the procedure conditions changed in the 4th procedure and whether side effects occurred by comparing it to the after photo.Therefore, for the above reasons, additional investigation is required for the medwatch case, and a report on the additional investigation will be made within 1 month at the most.

• Brand Name: SYLFIRM X
• Common Device Name: SYLFIRM X
• Manufacturer (Section D): VIOL CO.,LTD.; c-608, 609, 808, 809, bundang; c, 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer (Section G): VIOL CO.,LTD.; c-608, 609, 808, 809, bundang; c, 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer Contact: minyoung park ; c-608, 609, 808, 809, bundang technopark; c, 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• MDR Report Key: 21896773
• Report Number: 3009206941-2025-00002
• Device Sequence Number: 8387697
• Product Code: GEI
• UDI-Device Identifier: 08809502330101
• UDI-Public: (01)08809502330101(11)230317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: VOFX-WC16
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White