MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO DYE-VL

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Burn/scar on right cheek.

• Brand Name: HARMONY XL PRO DYE-VL
• Common Device Name: HARMONY XL PRO DYE-VL
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• MDR Report Key: 18859379
• Report Number: 3004450661-2024-00006
• Device Sequence Number: 16348198
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024
• Report Date (Section F): 03/07/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/15/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 03/07/2024