MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported about a burn and a scar on right cheek.
Additional Manufacturer Narrative
Potential scar on cheek due to a burn following harmony xl treatment.The user did not agree to return the system for technical investigation and did not provide any additional clinical information on the injury.This report is submitted as good will.
Event or Problem Description
It was reported about a burn and a scar on right cheek.
Additional Manufacturer Narrative
Potential scar on cheek due to a burn following harmony xl treatment.The user did not agree to return the system for technical investigation and did not provide any additional clinical information on the injury.This report is submitted as good will.Udi related data quality updates.This supplemental report represents a correction to a previously submitted mdr.

• Brand Name: HARMONY XL PRO
• Common Device Name: HARMONY XL
• 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: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 19009283
• Report Number: 3004167969-2024-00006
• Device Sequence Number: 9437777
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: (01)17290110120907(11)200303
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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
• Device Catalogue Number: AAHP02110623GAH10001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/31/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2020
• 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 Sex: Female