MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The importer reported that user facility reported that a patient experienced burns at the treatment site following use of the harmony xl pro system.
Additional Manufacturer Narrative
The importer reported that user facility reported that a patient experienced burns at the treatment site following the use of the harmony xl pro system.

• Brand Name: HARMONY XL PRO
• Common Device Name: HARMONY XL PRO
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; 30798 95; IS 3079895
• Manufacturer (Section G): ALMA LASERS, LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: odelia zerbiv ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 21934564
• Report Number: 3004167969-2025-00008
• Device Sequence Number: 14882662
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: (01)17290110120907(11)2024-01-17
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 47 YR
• Patient Sex: Female