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

Catalog Number	105-7041-000
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced burns, sores, and crusting on the leg following a leg vein treatment using elite iq.(b)(6) clinical reviewed the event and determined it was due to user error.(b)(6) clinical affirms, "provider used aggressive settings that in my assessment led to the adverse reaction.The provider used 15ms and 135j/cm2.The clinical reference guide (crg) recommendations are 50-10ms and 120-180.The provider should have used test spots starting at less then aggressive 50ms and 120j/cm2.The site did not give me all the details after numerous attempts, however still aggressive settings leading to response." crg instructs, "immediately following treatment, the area may appear flushed and warm, but there should be no bruising.Larger veins may require a longer pulse duration and a larger spot size to increase depth of penetration." crg also warns, "treating with excessive energy levels can result in adverse effects, such as abnormal pigmentation and scarring." on (b)(6) 2025, (b)(6) medical director was consulted for feedback regarding information and photos provided by site.(b)(6) medical director declares, "i see evidence of full thickness tissue loss from a burn.I agree with the thought that the parameters were too strong.I recommend that the necrotic tissue be debrided and the tissue cared for by someone familiar with burn care.I would expect the tissue to need 3-4 weeks to fill in and heal by secondary intention, but the necrosis needs to be removed to help that process.I would expect permanent scars to be a result.Once fully epithelialized, i recommend scar care.This could involve massage and silicone gel treatment.Also, microneedling or non-ablative fractional laser treatments done in series could be beneficial in helping reorganize and mature the scar." a service evaluation is not needed since user error was involved and there is no indication of a device malfunction.Due to patient experiencing full thickness tissue loss from a burn, 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: 22387351
• Report Number: 1222993-2025-00014
• Device Sequence Number: 15623225
• 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): 07/02/2025
• Report Date (Section F): 07/02/2025

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: 05/30/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/01/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• 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: Female
• Date Report Sent to FDA: 07/02/2025