MAUDE Adverse Event Report: INMODE LTD. MORPHEUS 8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/13/2021

Event Type  Injury  

Event Description

I received a morpheus 8 micro needling treatment on my face which resulted in unwanted permanent fat loss, changes in my face structure, indentations in my face which will require surgical repair.I also experienced severe head pain and had a brain mri following the treatment.

• Brand Name: MORPHEUS 8
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.
• MDR Report Key: 16122341
• MDR Text Key: 307011361
• Report Number: MW5114225
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/04/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White