MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM (BRANDNAME IGNITE RF) WITH QUANTUM HANDPIECE; GEI

Model Number	AG613237A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Full thickness (Third Degree) Burn (2696); Unspecified Blood or Lymphatic problem (4434)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the reporter chose to remain anonymous, inmode cannot obtain any additional clinical information, including photos, to enable clinical assessment of the complaint, nor establish the root cause.It was decided to report this incident based solely on patient's narrative.This report is submitted in compliance with fda regulations at 21 cfr part 803 and should not be considered to be an admission that any inmode product is defective or caused serious injury.
Event or Problem Description
An anonymous patient report submitted to fda (mw5182363 and mw5182364).A 56-year-old female patient complains about burn marks, scarring and prolonged severe pain following treatment with quantum rf for skin tightening on both arms, performed 1 year ago.The scarring is "similar to 3rd degree burn", according to the patient.Additionally, the patient complains about lymphatic damage: "my lymph nodes no longer drain properly.I have to wear compression devices and have regular lymphatic drainage massages and ultrasonic massages to relieve the pain.".

• Brand Name: INMODE RF SYSTEM (BRANDNAME IGNITE RF) WITH QUANTUM HANDPIECE
• Common Device Name: GEI
• 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: 24410500
• Report Number: 3010511300-2026-01031
• Device Sequence Number: 10605379
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K240780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 02/22/2026

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: AG613237A
• Device Catalogue Number: AG613237A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Race: White