MAUDE Adverse Event Report: INMODE LTD. LUMECCA; ONF

Model Number	AS601863A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient treated with lumecca on her nose bridge and décolleté, presenting with scarring due to second degree burns.Investigation concluded that the adverse event was caused by user errors: the operator used an excessive fluence on bony areas, exceeding the recommendations of inmode.This, combined with the short wavelength chosen by the operator, led to the thermal damage.Further, bad healing, typical of such bony areas, led to the formation of the scar tissue.The clinic has been retrained.
Event or Problem Description
Scarring on nose and décolleté following lumecca treatment.

• Brand Name: LUMECCA
• Common Device Name: ONF
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 21897600
• Report Number: 3010511300-2025-00812
• Device Sequence Number: 8162178
• Product Code: ONF
• UDI-Device Identifier: 07290016633108
• UDI-Public: 07290016633108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Notification,Other,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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 Model Number: AS601863A
• Device Catalogue Number: AS601863A
• 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: 04/11/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White