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

Catalog Number	105-7041-000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced scabbing and ulcers on the legs 2 weeks post spider vein removal treatment using elite iq.Cynosure's clinical team investigated the event and confirmed user error was involved.Operator did not perform patch test prior to treatment.Labeling instructs to always perform patch test prior to any treatment.The smartcool device was also used only before and after treatment, but not during treatment.Per clinical: this is a major contribution to the side effects reported.The burned lesions on the skin suggest that the wrong technique was used.Instead of using the spider veins technique, the operator used the laser hair removal technique.Cynosure medical director observed first, second and third degree burns and expects some permanent scarring in areas of full thickness tissue loss.Per cynosure medical director: patient will most likely experience surgical debridement and/or permanent scarring.Patient was seen by a burn nurse specialist on (b)(6) 2024 and was given neosporin, silicone ointment, and ciprofloxacine pills as preventative medication.Complimentary virtual training was dispatched to the site.Burns are expected side effects from laser treatments, however this event is reportable since permanent scarring is a likely outcome.

• 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: 19190834
• Report Number: 1222993-2024-00019
• Device Sequence Number: 12666614
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)230227
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024
• Report Date (Section F): 04/26/2024

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
• 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: 03/27/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2024
• 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: 04/26/2024