MAUDE Adverse Event Report: INMODE LTD. LUMECCA; ONF

Model Number	AS601864A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This case is reported following retrospective review and re-assessment of the case's seriousness.Patient presented with first and second degree burns spread over her right arm following lumecca treatment.Inmode recommended the patient to visit gp for draining the blister and apply additional products to keep the skin moist and to promote good healing.Although we do not have the information whether the patient eventually visited a physician or not to address the blister, due to the necessity of such intervention, the adverse event is being reported.Per latest update received at inmode, the burns healed and the patient was presenting with pigmentation changes, assumed to be transient.Investigation concluded the root-cause to be a user error: the operator did not perform a patch test as required by ifu and applied a very high fluence, not suitable for the patient's skin type.Additionally, the treatment provider applied ipl with high overlap, adding to the thermal damage to the skin.The clinic was retrained.
Event or Problem Description
Burns on arm 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: 22278103
• Report Number: 3010511300-2025-00334
• Device Sequence Number: 7047556
• Product Code: ONF
• UDI-Device Identifier: 07290016633115
• UDI-Public: 07290016633115
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring,Other,Notification
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: AS601864A
• Device Catalogue Number: AS601864A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2023
• 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: Required Intervention
• Patient Sex: Female
• Patient Race: White