MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Scar Tissue (2060); Hyperpigmentation (4837)
Date of Event	10/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient presenting with pie, pih and uneven skin texture on her face 5 months following morpheus8 treatment.Investigations is ongoing.
Event or Problem Description
Pie, pih and uneven skin texture on face 5 months post moprheus8 treatment.
Additional Manufacturer Narrative
Patient presenting with pie, pih and uneven skin texture on her face 5 months following morpheus8 treatment.Investigation is ongoing.On 30-jun-2025: follow-up report is submitted with investigation conclusions.Section h6 has been updated.The clinic confirmed that this is an isolated incident and therefore no technical inspection of the device was performed.Treatment settings are unknown despite several attempts to get this information from the clinic.During retraining visit, inmode's trainer noticed a bad technique (moving the handpiece before full needle retraction).The initial intense inflammatory reaction was most probably triggered by the numbing cream and exacerbated by morpheus8 procedure, especially if the technique was incorrect.The clinic reported that the patient has completely healed.
Event or Problem Description
Pie, pih and uneven skin texture on face 5 months post moprheus8 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: 21811740
• Report Number: 3010511300-2025-00799
• Device Sequence Number: 8834853
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 Practitioner
• Remedial Action: Notification,Patient Monitoring,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2022
• 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: 31 YR
• Patient Sex: Female
• Patient Race: White