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

Model Number	AG613237A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information provided by the treating nurse, the patient did not adhere to post treatment recommendations and went to sauna/exercised within the first 48hrs following the procedure.Such nonadherence to aseptic conditions following an invasive procedure resulted in the reported secondary infection.No sterility complaints have been received for quantum 25, as confirmation that the infection was secondary to the device use and related to patient's incorrect behavior following the procedure.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
Treatment provider reported of a female patient developing a secondary infection in her right anteromedial thigh following treatment with quantum 25.On the provided photo of 7 days post tx, a large inflamed red area can be seen, consistent with cellulitis.According to the treatment provider, the patient is currently taking antibiotics and seems to be improving.

• 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: 24921020
• Report Number: 3010511300-2026-01080
• Device Sequence Number: 14747575
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/19/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2026
• Initial Report FDA Received Date: 04/19/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: White