MAUDE Adverse Event Report: ALMA LASERS LTD ALMA LIPOFLOW SYSTEM; LIPOPLASTY

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Breast Mass (2439)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A routine mammogram performed found a small unidentified mass present on the left breast not previously present in previous mammograms.

• Brand Name: ALMA LIPOFLOW SYSTEM
• Common Device Name: LIPOPLASTY
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; caesarea, ha zafon 30798 95; IS 3079895
• MDR Report Key: 11828822
• Report Number: 3004450661-2021-00005
• Device Sequence Number: 19875549
• Product Code: MUU
• UDI-Device Identifier: 17290110121447
• UDI-Public: 17290110121447
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2021
• Report Date (Section F): 05/04/2021

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: AALP24091503
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/04/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Date Report Sent to FDA: 05/04/2021