MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM (BRAND NAME IGNITE RF) WITH FACETITE HANDPIECE; GEI

Model Number	AG613237A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Superficial (First Degree) Burn (2685); Fibrosis (3167)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was inspected and the technical issue revealed was determined to be not related to the reported burn.However, the investigation could not conclude the final root cause for the reported adverse events due to lack of clinical information.The clinic has not provided the clinical form nor photos.A retraining has been offered to the clinic and inmode continues to monitor patient's healing.If additional information becomes available, inmode will submit a supplementary report.
Event or Problem Description
A doctor reported of a female patient treated with facette on her face and sustaining a small burn on her right jowl (that healed with no sequelae), and an abscess that resolved following treatment with antibiotics, leaving an induration (most probably a fibrotic lump) in the submentum.

• Brand Name: INMODE RF SYSTEM (BRAND NAME IGNITE RF) WITH FACETITE 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: 25498820
• Report Number: 3010511300-2026-01110
• Device Sequence Number: 18788921
• Product Code: GEI
• UDI-Device Identifier: 07290019863250
• UDI-Public: 07290019863250
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K251254
• 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: Physician
• Remedial Action: Notification,Patient Monitoring,Other,Inspection
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

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
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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; Other
• Patient Age: 20 YR
• Patient Sex: Female