MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted following patient's complaint to fda (# mw5164341).According to the patient, she underwent several morpheu8 treatments 1.5 years ago for her existing hypertrophic scars, which allegedly got worse after the treatment.Since the patient chose to remain anonymous and no contact details are available, we cannot obtain any additional information and clinically assess the case.The case was assessed as reportable based solely on patient's narrative.It is plausible to assume that the patient already had an individual predisposition to hypertrophic scarring, since it was a pre-existing condition.Nevertheless, due to lack of contact details, exact root cause cannot be established.
Event or Problem Description
This report is submitted following patient's report to fda mw5164341, claiming "my scars got worse and caused more scarring" 1.5 years post 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: 21261957
• Report Number: 3010511300-2025-00758
• Device Sequence Number: 4273443
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 01/29/2025

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: AG607401A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2025
• Initial Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2021
• 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic
• Patient Race: White