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

Model Number MORPHEUS 8

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Scar Tissue (2060); Depression (2361)

Event Date 06/06/2022

Event Type  Injury  

Event Description

In mode morpheus8 machine cause severe side effects.Burns, scars and permanent damage that i am still working with the team almost a year later to resolve.It's been horrific, caused depression and hard to think that it will ever be any better.This device has negatively impacted my life and needs to be reviewed.Have had numerous follow up procedures to try and remedy the damage done by in modes morpheus8.

• Brand Name: IN MODE MORPHEUS 8
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.
• MDR Report Key: 17005156
• MDR Text Key: 316090086
• Report Number: MW5117874
• 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: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MORPHEUS 8
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention