MAUDE Adverse Event Report: LUTRONIC CORPORATION LASEMD ULTRA

Catalog Number	1120200330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pronounced edema post soft tissue coagulation treatment with a lasemd ultra device.Cynosure lutronic clinical team collected additional information and determined the case to be inconclusive.Site physician suspects the patient had an allergic type response.Treatment parameters used were within the recommended range.Numbing cream was applied prior to treatment.Post treatment be facial mask, vitamin c ampoule, prednisone atar and healite treatment were applied as preventative.Patient reported the following day after treatment that her face was more swollen and she was unable to see.Site confirmed patient had severe periorbital edema and clear yellow drainage.The case was discussed with an infectious disease doctor, who recommended that the patient receive direct admission for iv antibiotics and iv steroids.The patient received v ancef, clindamycin and solumedrol.Labs showed leukocytosis 13 > 15, elevated lactic acid, 3.3.Following the iv treatment it was reported that these numbers trended down as expected.The patient was discharged two (2) days later and it was reported that they recovered well and can see significant improvement.A cynosure lutronic field service engineer (fse) arrived on site and performed a device evaluation.The device was subjected to multiple tests including full functionality testing and had passing results.Device confirmed to be operating within specification.Due to patient receiving medical intervention, this event is reportable.

• Brand Name: LASEMD ULTRA
• Common Device Name: LASEMD ULTRA
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 22521283
• Report Number: 1222993-2025-00015
• Device Sequence Number: 8058464
• Product Code: GEX
• UDI-Device Identifier: 08809447653044
• UDI-Public: 08809447653044
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2025
• Report Date (Section F): 07/16/2025

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: Health Professional
• Device Catalogue Number: 1120200330
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/16/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• 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; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/16/2025