MAUDE Adverse Event Report: LUTRONIC CORPORATION DERMAV

Catalog Number	1011600300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced erythema more than 2 months post rosacea treatment on the mid face and cheeks using dermav.This was reported to be the patients fifth (5th) treatment in total.Cynosure lutronic field service engineer (fse) went to site to perform device evaluation.During visual inspection, cynosure lutronic fse found a spot on the adapter lens for the 15,18,22.The customer was instructed how to clean the lens and handpiece window.A small permanent mark was also observed on the lens in the spot size adapter.Fse recommended that the provider order new lens for the 15,18,22.It is unknown if these findings contributed to the patients reported side effects.Cynosure lutronic clinical reached out to the site to collect additional information.Cynosure lutronic clinical determined the event to be inconclusive.The treatment parameters used for the most recent treatment were reviewed and found to be within recommended settings.Cynosure lutronic clinical states, "it is unknown if erythema was present before beginning treatment and it is unknown how the skin reacted to treatment without after treatment images." the patient was prescribed elta md moisture seal cream and is currently being treated by a plastic surgeon and dermatologist.During patient follow up post treatment, edema has resolved and erythema has improved.The event is reportable due to patient following up with care from a plastic surgeon and dermatologist as medical intervention.

• Brand Name: DERMAV
• Common Device Name: DERMAV
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 22738119
• Report Number: 1222993-2025-00019
• Device Sequence Number: 20260690
• Product Code: GEX
• UDI-Device Identifier: 08809447655260
• UDI-Public: 08809447655260
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2025
• Report Date (Section F): 08/07/2025

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
• Operator of Device: Other
• Device Catalogue Number: 1011600300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/07/2025