MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Catalog Number	AG607401A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient with skin type v-vi, presented with a small linear keloid scar (of ~4mm in length) 1 month post morpheus8 treatment, situated on the border of the left upper malar and periorbital regions.No technical issues were found in the device during inspection.No earlier post treatment photos were taken, and therefore it's unknown whether some lesion preceded the formation of this keloid scar.Treatment settings were very conservative and presumably could not have caused a burn.However, the operator used a tip compatible with larger treatment areas than the periorbital, which could have led to incomplete contact and a burn.Also, it's unknown whether the patient was aware of her predisposition to keloid scar formation, which is included in the contraindications list, and declared this to the operator.The exact root cause of this scar cannot be established, and the case is reported based on the low probability of its relatedness to morpheus8 device.
Event or Problem Description
Keloid scar under left eye.

• 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: 21889603
• Report Number: 3010511300-2025-00808
• Device Sequence Number: 11623770
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210492
• 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: Nurse
• Remedial Action: Inspection,Patient Monitoring,Other,Notification
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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 Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American