MAUDE Adverse Event Report: ALMA LASERS LTD ALMA HARMONY

Catalog Number	AAHG25102201BR0002
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074); Blister (4537)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The importer reported that a user facility reported that a patient experienced burns and blistering at the treatment site resulting skin discoloration following use of alma harmony system.This incident should resolve within several months and is being reported in good faith.
Event or Problem Description
The importer reported that user facility reported that a patient experienced burns and blistering at the treatment site resulting skin discoloration following use of the alma harmony system.
Event or Problem Description
The importer reported that user facility reported that a patient experienced burns and blistering at the treatment site resulting skin discoloration following use of the alma harmony system.
Additional Manufacturer Narrative
The importer reported that a user facility indicated a patient experienced burns and blistering at the treatment site, resulting in skin discoloration, following use of the alma harmony system.The event is expected to resolve within several months and was reported in good faith.A follow-up investigation was conducted by the importer, during which the device was tested and found to meet all applicable specifications and performance requirements.No device/applicator malfunction was identified.Based on the investigation results, the event was concluded to be attributable to user error.Uf/importer report #: (b)(4).
Additional Manufacturer Narrative
The importer reported that a user facility indicated a patient experienced burns and blistering at the treatment site, resulting in skin discoloration, following use of the alma harmony system.The event is expected to resolve within several months and was reported in good faith.A follow-up investigation was conducted by the importer, during which the device was tested and found to meet all applicable specifications and performance requirements.No device/applicator malfunction was identified.Based on the investigation results, the event was concluded to be attributable to user error.
Event or Problem Description
The importer reported that user facility reported that a patient experienced burns and blistering at the treatment site resulting skin discoloration following use of the alma harmony system.

• Brand Name: ALMA HARMONY
• Common Device Name: ALMA HARMONY
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 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: 23573479
• Report Number: 3004167969-2025-00022
• Device Sequence Number: 10272763
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233024
• 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,Followup,Followup
• Report Date (Section B): 03/10/2026

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: AAHG25102201BR0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 10/17/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/18/2025; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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: 44 YR
• Patient Sex: Female