MAUDE Adverse Event Report: ALMA LASERS LTD OPUS

Catalog Number	AASP12091701BA0001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The importer reported that user facility reported that a patient developed a facial swelling at the treatment site following the use of the opus system.As a result, the user facility alleged that the patient experienced an airway compromise which required emergency medical attention and steroids for treatment.
Event or Problem Description
The importer reported that user facility reported that a patient developed a facial swelling at the treatment site following use of the opus system.As a result, the user facility alleged that the patient experienced an airway compromise which required emergancy medical attention and steroids for treatment.

• Brand Name: OPUS
• Common Device Name: OPUS
• 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: odelia zerbiv ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 22080519
• Report Number: 3004167969-2025-00011
• Device Sequence Number: 8397919
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)230427
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• 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
• Report Date (Section B): 05/23/2025

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: AASP12091701BA0001
• 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: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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: Required Intervention
• Patient Sex: Unknown