MAUDE Adverse Event Report: ALMA LASERS LTD. ALMA LIPODIODE SYSTEM 1470 110V

Catalog Number	AALP03121311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient developed an infection at the treatment site following the use of the alma lipodiode system 1470.As a result, the patient was hospitalized for three days and required a drain tube and iv antibiotics for treatment.

• Brand Name: ALMA LIPODIODE SYSTEM 1470 110V
• Common Device Name: ALMA LIPODIODE SYSTEM 1470 110V
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 21316889
• Report Number: 3004450661-2025-00003
• Device Sequence Number: 8564668
• Product Code: GEX
• UDI-Device Identifier: 17290110121317
• UDI-Public: 17290110121317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2025
• Report Date (Section F): 02/05/2025

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: AALP03121311
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• 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: Hospitalization
• Patient Sex: Female
• Date Report Sent to FDA: 02/05/2025