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	Pain (1994); Blister (4537); Swelling/ Edema (4577)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced pain, pronounced edema, and blisters on the upper lip following a laser hair reduction treatment using elite iq.Patient moved and laser was pulsed inside the vermillion border.Patient was given 1% hydrocortisone and fucidin as preventative medication.Patient was also prescribed oral steroid, but did not take the medication.Patient reported visiting the emergency room and receiving an anti-inflammatory injection.Treatment settings used were within guidelines, although aggressive.Cynosure medical director reviewed the incident and advise oral steroid and a follow up with a dermatologist or plastic surgeon.Site confirms patient is almost healed during a follow up visit on (b)(6) 2024.The device was evaluated and found to be operating as intended within specification.Pain, edema, and blister are expected side effects from laser treatments, however this event is reportable due to medical intervention.

• 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: 19643406
• Report Number: 1222993-2024-00034
• Device Sequence Number: 6587153
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)221108
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2024
• Report Date (Section F): 07/01/2024

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
• 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: 06/01/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2024
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 07/01/2024