MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Scar Tissue (2060); Localized Skin Lesion (4542)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted following patient's report to fda.Since the reporter chose to remain anonymous, no contact details are available.Therefore, inmode could not obtain photos or any additional clinical information which would enable a thorough assessment of this incident.The root cause therefore could not be established.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 inmode will submit a supplementary report if additional information becomes available.
Event or Problem Description
This report is submitted following a report to fda (mw5179567) submitted by a female patient complaining about open wounds and scarring to face lasting 6+ months, following morpheus8 treatment.

• Brand Name: MORPHEUS8
• 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: 23892162
• Report Number: 3010511300-2025-00998
• Device Sequence Number: 11059558
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 12/25/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/25/2025
• 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 Sex: Female
• Patient Weight: 61 KG
• Patient Race: White