MAUDE Adverse Event Report: ALMA LASERS LTD. HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
There was a report of a second degree burn post treatment with the harmony xl pro system that we have been unable to confirm due to lack of photo evidence, therefore we are filing this report in good faith.

• Brand Name: HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)
• Common Device Name: HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 21183672
• Report Number: 3004450661-2025-00002
• Device Sequence Number: 19899080
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: 17290110120907
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/17/2025
• Report Date (Section F): 01/17/2025

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: Health Professional
• Device Catalogue Number: AAHP02110623GAH10001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• 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 Sex: Female
• Date Report Sent to FDA: 01/17/2025