MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Burn(s) (1757); Hyperpigmentation (4837)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burn with post inflammatory hyperpigmentation (pih) after harmony hr.The pih may not completely resolve.Background medication being used (hydrochlorothiazide) may increase photosensitivity and increase risk of burns.
Event or Problem Description
It was reported about a burn with post inflammatory hyperpigmentation following the harmony xl pro hr 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: 20556652
• Report Number: 3004167969-2024-00025
• Device Sequence Number: 8886315
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: (01)17290110120907(11)21-06-04
• 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): 10/29/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2021
• 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