MAUDE Adverse Event Report: INMODE LTD. INMODE MORPHEUS8 APPLICATOR FRACTIONAL RF SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AG606991A
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	01/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Mandibular nerve palsy on the right side, post morpheus8 treatment most probably due to the administration of nerve block.Fda safety report id# (b)(4).

• Brand Name: INMODE MORPHEUS8 APPLICATOR FRACTIONAL RF SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.
• MDR Report Key: 13652383
• Report Number: MW5107817
• Device Sequence Number: 12011004
• Product Code: GEI
• UDI-Device Identifier: 07290016633375
• UDI-Public: 07290016633375
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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: AG606991A
• Device Catalogue Number: AG606666A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White