MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL CONSOLE

Catalog Number	AAHP02110613
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Hyperpigmentation (4837)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hyperpigmentation and pinpoint depressions after colibri to eyelids.May stay or resolve with further treatments.
Event or Problem Description
It was reported about hyperpigmentation and pinpoint depression following the opus colibri treatment.
Additional Manufacturer Narrative
Udi related data quality updates only.Burn with ulceration after leg vein treatment with lp 1064nm laser, will likely scar.This supplemental report represents a correction to a previously submitted mdr, ae # (b)(4), mfr report #: 3004167969-2023-00013.The correction is performed following fda request, the udi number was added.
Event or Problem Description
It was reported about a burn with ulceration post harmony xl treatment.

• Brand Name: HARMONY XL CONSOLE
• 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: 19971743
• Report Number: 3004167969-2024-00022
• Device Sequence Number: 20978907
• Product Code: GEX
• UDI-Device Identifier: 17290110120884
• UDI-Public: (01)17290110120884(11)21-07-28
• 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): Unknown
• 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: AAHP02110613
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2013
• 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: 28 YR
• Patient Sex: Female
• Patient Race: White