MAUDE Adverse Event Report: ALMA LASERS LTD. ALMA HARMONY; POWERED LASER SURGICAL INSTRUMENT

Model Number	1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that one of their staff members experienced a burn at the treatment site during self use of the alma harmony system.

• Brand Name: ALMA HARMONY
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 23097122
• Report Number: 3004450661-2025-00019
• Device Sequence Number: 13091657
• Product Code: GEX
• UDI-Device Identifier: 07290110123376
• UDI-Public: 07290110123376
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/19/2025
• Report Date (Section F): 09/19/2025

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 Model Number: 1
• Device Catalogue Number: AAHG25102201BR0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2025
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• 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: 09/19/2025