MAUDE Adverse Event Report: EL. EN. ELECTRONIC ENGINEERING SPA ELITE IQ

Catalog Number	105-7041-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	12/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced a burn on the upper lip and cheek following a laser hair removal treatment using elite iq.Cynosure clinical reviewed the event and determined it was inconclusive.Site failed to provide any additional information regarding the incident despite clinical's multiple requests for patient and treatment details.On 24 feb 2025, cynosure clinical was updated with additional information and photos of the patient.Cynosure medical director reviewed the images and states, "the new image reveals a thickened area of hypertrophic scar, secondary to the burn.Recommendations for treatment are massage, silicone topical, and non ablative fraction laser or micro needling." the device was evaluated and found to be operating as intended within specification.Root cause as to why the patient sustained a burn/scarring is unknown since there is insufficient information at this time.Cynosure will continue to monitor such complaints.Burns are an expected side effect from such treatment.As scarring post treatment was reported from the event, this is considered a permanent injury and therefore reportable.

• Brand Name: ELITE IQ
• Common Device Name: ELITE IQ
• Manufacturer (Section D): EL. EN. ELECTRONIC ENGINEERING SPA; via baldanzese 17; calenzano 50041 ; IT 50041
• MDR Report Key: 21699488
• Report Number: 1222993-2025-00007
• Device Sequence Number: 8635955
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)220114
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/26/2025
• Report Date (Section F): 03/26/2025

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: 105-7041-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• 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: Disability
• Patient Sex: Female
• Date Report Sent to FDA: 03/26/2025