MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Post-inflammatory erythema and linear depressed scar that may not resolve completely.The opus glide tip (accessory of the opus system) used in this event was not returned to investigation.Samples of glide tips were investigated and found to be defective.The inventory was scanned and all defect tips were scrapped.
Event or Problem Description
It was reported about scarring following the opus glide treatment.
Event or Problem Description
It was reported about a burn following the harmony xl treatment.
Additional Manufacturer Narrative
Burns post harmony xl (dye-vl) treatment.Most likely will leave scars.The information about the day of event is not available.Udi related data quality updates only: this supplemental report represents a correction to a previously submitted mdr, ae # (b)(6), #:mfr report #: 3004167969-2023-00015.The correction is performed following fda request, the udi number was added.

• Brand Name: HARMONY XL PRO
• Common Device Name: 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: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 19990733
• Report Number: 3004167969-2024-00023
• Device Sequence Number: 7057624
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: (01)17290110120907(11)18-07-01
• 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,Followup
• Report Date (Section B): 10/02/2024

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: 07/31/2024
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2019
• 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