MAUDE Adverse Event Report: SHENB CO. LTD. VIRTUE RF; VIRTUE RF MICRONEEDLING

Model Number	VIRTUE RF
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
On december 30, 2025, cartessa aesthetics became aware of a reported adverse event submitted by a patient, converning the shenb virtue rf microneedling device via fda medwatch report #mw5180017.The adverse event reported was: "virtue rf microneedling left me with depression scars/tram track scarring." no information about the date the reported event occurred, the site where the reported event took place nor any information about the name of the actual physician who performed the treatment nor any id information about the device has been disclosed in the report.A review of internal complaint logs, adverse event logs, service requests and emails did not produce any information about the actual device involved in the event nor any information about the site or actual physician involved in the event.As such, we are unable to inspect the device nor contact the physician that performed the treatment to gather details and formally investigate.We, the initial importer and distributor of the device in the united states, became aware of the reported event on december 30, 2025, by email via fda medwatch report mw5180017.On december 30, 2025, cartessa aesthetics notified the device manufacturer, shenb co.Ltd.Of the receipt of mw5180017.Per 21 cfr part 803, and with the support of the manufacturer, we have evaluated this event as not reportable due to the fact that scarring and track marks are common and expected after treatment with this device.Following proper post-treatment care, these heal in 1-2 weeks.We don't find that this case meets the criteria for reporting an adverse event.We will continue to investigate the origin of this reported event and will update this response if we are able to gather additional details.

• Brand Name: VIRTUE RF
• Common Device Name: VIRTUE RF MICRONEEDLING
• Manufacturer (Section D): SHENB CO. LTD.; shenb tower, 74 achasan-ro; seongdong-gu; seoul, 04782 ; KS 04782
• MDR Report Key: 24164663
• Report Number: 3013602304-2026-00001
• Device Sequence Number: 21145225
• Product Code: GEI
• UDI-Device Identifier: 08800017100715
• UDI-Public: 08800017100715
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2026
• Report Date (Section F): 01/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: VIRTUE RF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2025
• Event Location: Other
• Date Report to Manufacturer: 12/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White
• Date Report Sent to FDA: 01/23/2026