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

Catalog Number	105-7041-000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Site reported patient experiencing side effects approximately five (5) weeks post vascular treatment on the legs using elite iq pro.(b)(6) clinical determined the event to be user error.Laser parameters used were within normal range, however the short pulse duration of 10ms was not appropriate for the blood vessels visible in the pre-treatment images.Clinical reference guide (crg) recommends, "pulse duration of 50-10 ms for safer and more effective treatment of larger vessels." clinical expresses, "pulses should be delivered in a linear fashion with less than 10% overlap." the treatment performed had approximately 10% overlap.Crg advises using conductive gel as a conduit for laser energy, but no coating gel was used.Crg recommends "use of cold packs (not ice) both before and after treatment, especially for larger veins." patient has a history of varicose veins, which raises concerns about her suitability for this type of treatment.It remains unclear whether the side effects were exacerbated by her 8-9 hour flight four days after her second session or by any possible sun exposure to the treated area.On 27 june 2025, (b)(6) medical director was consulted for feedback regarding information and photos provided by site.(b)(6) medical director states, "right leg has a full thickness burn, and it is currently in the healing phase.Scarring may occur in that area and recommends initiating local scar care, including massage, as well as consistent sunscreen use and avoidance of sun exposure." patient was given mupirocin and mometasone as preventative medication.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: 22609399
• Report Number: 1222993-2025-00017
• Device Sequence Number: 5384402
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)210804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2025
• Report Date (Section F): 07/25/2025

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: 06/27/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• 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 Age: 41 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/25/2025