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); Hypopigmentation (4838)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burn with hypopigmentation after harmony treatment.
Event or Problem Description
It was reported about a burn with hypopigmentation following the harmony xl pro treatment.

• 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: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 20543017
• Report Number: 3004167969-2024-00026
• Device Sequence Number: 7225298
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: (01)17290110120907(11)23-08-09
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072564
• 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
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Health Professional
• 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: 10/07/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2023
• 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