MAUDE Adverse Event Report: INMODE LTD. BODYTITE; GEI

Model Number	AG606969A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Necrosis (1971); Scar Tissue (2060); Deformity/ Disfigurement (2360); Full thickness (Third Degree) Burn (2696)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Full thickness burns with necrosis, disfigurement, and scarring following abdominoplasty, liposuction and bodytite procedures.
Additional Manufacturer Narrative
A female patient, reported to be a brazilian citizen, alleged that she sustained full-thickness burns with necrosis, disfigurement, and scarring following a cosmetic procedure performed approximately three and a half years prior to this report.According to the patient, the procedure included liposuction using a non-inmode device, abdominoplasty using non-inmode devices, and treatment with an inmode bodytite device.Inmode has initiated an investigation into this event.Based on the information currently available, a definitive root cause has not been established; however, involvement of the inmode device as a possible cause or contributory factor to the reported injuries cannot be ruled out.Accordingly, inmode is submitting this report in accordance with applicable reporting requirements under 21 c.F.R.Part 803.This report is submitted to comply with fda medical device reporting regulations and does not constitute an admission by inmode that any product malfunctioned, is defective, or caused or contributed to a serious injury.Inmode has provided all relevant information known to the company as of the submission date of this report and will submit a supplemental report if additional relevant information becomes available.

• Brand Name: BODYTITE
• 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: 23802038
• Report Number: 3010511300-2025-00976
• Device Sequence Number: 9270651
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: AG606969A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Disability
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White