MAUDE Adverse Event Report: INMODE LTD. Morpheus8; GEI

Model Number	AG613055A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Localized Skin Lesion (4542)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Investigation is ongoing.Inmode will submit a supplementary report upon completion of investigation.
Event or Problem Description
A female patient treated with morpheus8 presenting with lesions on her cheeks that according to the patient developed 2-3 days post treatment and are accompanied with pain.On the provided photos a skin eruption resembling a herpetic rash can be seen.Secondary mycotic infection cannot be excluded.On the left cheek two circular lesions resembling erythema multiforme can be seen.Although at the time of this report the exact diagnosis is unknown, due to the medical intervention required for these hypothesized conditions, the case is reported to fda.

• 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: 25712305
• Report Number: 3010511300-2026-01121
• Device Sequence Number: 14707154
• Product Code: GEI
• UDI-Device Identifier: 07290019863120
• UDI-Public: 07290019863120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251632
• 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: Administrator/Supervisor
• Remedial Action: Patient Monitoring,Notification,Other,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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: AG613055A
• Device Catalogue Number: AG613055A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/05/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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: Other; Required Intervention
• Patient Sex: Female