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	Full thickness (Third Degree) Burn (2696)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a burn on the forehead and nose following a treatment using elite iq.Patient was given aquaphor, bacitracin, and prednisone as preventative medication post treatment.Settings on forehead between brows was lhr 1064nm yag 12mm spot 30jcm2 20ms, and on the nose was 2.5mm 120 j/cm2 30ms.Operator also noted zimmer hose was not connecting properly and wanted a device evaluation.A service evaluation was performed with cynosure field service engineer (fse) confirming zimmer hose at handpiece end was damaged and being held together by tape.The tape was squeezing the zimmer hose and could be restricting airflow and affecting the skin cooling efficiency.Fse relayed to site that hose should have been replaced.Power output was confirmed to be within specification and was not the reason for the burns experienced.Cynosure clinical reached out to the site for additional information.Images of the patient was also provided and showed patient may have received potential sun exposure before or after treatment.Site also relayed that one of the treatments was performed with too much overlap.Per cynosure clinical, "it is unknown if overlap contributed to the burns." the burn experienced was confirmed by cynosure's medical director to be a small thickness burn between the eyebrows.Cynosure's medical director recommended to cleanse 2-3 times a day, apply a thin layer of aquaphor, and avoid sun exposure.Also, cynosure's medical director's opinion was that prednisone was not necessary.Burns are an expected side effect from such treatment.Since a full thickness burn occurred from this event, this is considered a serious 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: 23368494
• Report Number: 1222993-2025-00050
• Device Sequence Number: 9931992
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)220713
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/23/2025
• Report Date (Section F): 10/23/2025

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: 09/26/2025
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2025
• 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: Other
• Patient Sex: Male
• Date Report Sent to FDA: 10/23/2025