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

Model Number	M122B1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Blister (4537)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced blisters on the legs following a treatment using elite iq.The device was evaluated and found to be operating as intended within specification.User error was confirmed during clinical evaluation.The skin was not cooled prior to treatment and site likely performed more than one pass over the treated area.Labeling advises: adverse effects may be reduced by cooling the area to be treated prior to treatment and removing all makeup, lotions or creams from that area.Patient was given peroxide and polysprine as preventative medication.Blisters are expected side effects from laser treatments, however permanent scarring is a likely outcome 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: 17084638
• Report Number: 1222993-2023-00005
• Device Sequence Number: 16845366
• Product Code: GEX
• UDI-Device Identifier: 08057017760450
• UDI-Public: (01)08057017760450(11)220126
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2023
• Report Date (Section F): 06/08/2023

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 Model Number: M122B1
• Device Catalogue Number: 105-7041-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/11/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2023
• 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: 06/08/2023