MAUDE Adverse Event Report: ALMA LASERS, LTD. 1470 DIODE; POWERED LASER SURGICAL INSTRUMENT

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Breast Discomfort/Pain (4504)
Date of Event	02/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had undergone liposuction to the abdominal area and fat transfer into the breast.The patient was prescribed antibiotics to treat the affected area and had an incision/drainage procedure on the affected area.The device was evaluated and found to be operating as intended, side effects from infection were not caused by the laser treatments, but reportable in this incident since the patient had an intervention procedure.
Event or Problem Description
The patient had medical intervention for a swollen breast.

• Brand Name: 1470 DIODE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS, LTD.; 18 haharash street; north industrial park; caesarea ha zafon, israel 30798 95; IS 3079895
• MDR Report Key: 11631570
• Report Number: 3004450661-2021-00003
• Device Sequence Number: 11676913
• Product Code: GEX
• UDI-Device Identifier: 17290110121317
• UDI-Public: 17290110121317
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/08/2021
• Report Date (Section F): 04/06/2021

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 Model Number: 1
• Device Catalogue Number: AADS03021302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/08/2021
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2021
• 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; Required Intervention
• Patient Age: 33 YR
• Date Report Sent to FDA: 04/06/2021