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 Codes	Partial thickness (Second Degree) Burn (2694); Blister (4537)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced blisters and irritation following hair removal treatment using elite iq.Blisters were caused by second degree burn.Cynosure clinical team investigated the event and determined it was inconclusive.Parameters used were within the guidelines.Site relayed patient's previous treatments resulted in a pronounced histamine response, but this treatment was even more pronounced.Patient mentioned she took cold baths when treatment area felt hot.Cynosure clinical states, "warm or hot baths can contribute to adverse responses.It is unknown if the bath was warmer than it should have been." patient applied hydrocostione post treatment as preventative medication.Patient also informed site they visited a burn clinic on (b)(6) 2025, and treatment area was debrided.Cynosure assistant medical director reviewed the images provided and confirms patient healing appropriately without infection, but it is unknown if there will be a permanent injury.Cynosure field servicer engineer (fse) arrived on site and evaluated the device.Fse confirmed device was operating as intended within specification.Blisters and burns are expected side effects from such treatment.Since patient had area debrided, this is considered medical intervention and is 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: 23016681
• Report Number: 1222993-2025-00037
• Device Sequence Number: 15830689
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)221010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/10/2025
• Report Date (Section F): 09/10/2025

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 09/10/2025