MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number AG607401A

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Suicidal Ideation (4429); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2022

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 327080562
• Report Number: 3010511300-2023-00377
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Race: White