MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM WITH FACETITE HANDPIECE; GEI

Model Number	AG606969A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported to inmode representative about a patient sustaining "full thickness burns on the lower facial nasolabial fold area and 4 burns per arm".
Additional Manufacturer Narrative
This report is submitted out of abundance of caution, although up to date no photos/clinical evidence has been provided to inmode.Inmode is currently performing attempts to collect the clinical information from the doctor.Investigation is ongoing.Supplementary report will be submitted upon receipt of additional information.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.
Additional Manufacturer Narrative
This report is submitted out of abundance of caution, although up to date no photos/clinical evidence has been provided to inmode.Inmode is currently performing attempts to collect the clinical information from the doctor.Investigation is ongoing.Supplementary report will be submitted upon receipt of additional information.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.On 16-apr-2026: fu report is submitted with additional information and investigation conclusions: patient information has been added.Event description has been updated.Event date has been added.Device has been updated to inmode rf system with facetite handpiece.Investigation conclusions: no technical issues were identified upon system inspection.Investigation attributed the burn and the subsequent scarring to user error: combination of excessive temperatures used by the doctor , not congruent with inmode's recommended protocol, and incorrect technique: staying too long on the same spot pulsing continuously.The doctor has received a retraining.
Event or Problem Description
Doctor reported to inmode representative about a patient sustaining "full thickness burns on the lower facial nasolabial fold area and 4 burns per arm".The provided photos showed a female patient with a linear scar of ~1.5cm in length near the left marionette fold, preceded by a full thickness burn, following facetite procedure.

• Brand Name: INMODE RF SYSTEM 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: 24442044
• Report Number: 3010511300-2026-01026
• Device Sequence Number: 18754060
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K151793
• 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: Patient Monitoring,Other,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: AG606969A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2022
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Race: White