MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Scar Tissue (2060); Suicidal Ideation (4429); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since this complaint was submitted anonymously by the patient to fda, inmode cannot confirm the alleged adverse events.Inmode made efforts to search for matching complaints in our databases.However we could not link this complaint to any known incident.Despite the fact that inmode could not perform any investigation of the alleged adverse events due to lack of contact details and data, it was decided to report this incident to fda based on patient's narrative.
Event or Problem Description
This complaint was initially submitted by a patient directly to fda (mw5146472) regarding a treatment with morpheus8 she underwent in (b)(6) 2022 to reduce facial scars following a car accident that happened 20 years ago.The patient complained about skin burning sensation, elasticity and fat loss, scarring, feeling suicidal and orange-peel textured skin.The patient states that she has seen some improvement in her condition following fillers and chemical peels.
Additional Manufacturer Narrative
The complaint was initially submitted anonymously by the patient to fda, but inmode could not perform any investigation of the alleged adverse events due to lack of contact details and data.Later, the patient contacted inmode and provided photos on which uneven skin texture could be seen on the left malar area, and an elongated flat scar on the right malar region (most probably the scar from the previous car accident that the patient intended to treat with morpheus8).The chronology of the photos is unknown as the patient only stated that they were taken during the 12 months period post treatment.The patient mentioned she did fillers and peeling after morpheus8 that improved the condition, but the chronology of the photos relative to these procedures is also unknown.Further, the patient became non responsive.The provider did not provide any information regarding the treatment despite multiple attempts to request for it.The other events claimed by the patient could not be confirmed based on the provided photos.The investigation could not deduce the root cause due to the limited information available to inmode and lack of cooperation on patient's and provider's side.
Event or Problem Description
This complaint was initially submitted by a patient directly to fda (mw5146472) regarding a treatment with morpheus8 she underwent in (b)(6) 2022 to reduce facial scars following a car accident that happened 20 years ago.The patient complained about skin burning sensation, elasticity and fat loss, scarring, feeling suicidal and orange-peel textured skin.The patient states that she has seen some improvement in her condition following fillers and chemical peels.

• 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: 18048320
• Report Number: 3010511300-2023-00377
• Device Sequence Number: 7427351
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K192695
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Race: White