MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inmode performed investigation of the incident and the root cause was attributed to user error and additional factors not related to the device.The treatment with the morpheus8 was absolutely excessive and extremely aggressive.In addition, the healing was further delayed by aggressive procedures that followed the morpheus8 treatment.It is evident that the tissue repair process has undergone regressions and inflammatory flare-ups due to a multitude of therapeutic interventions which, instead of calming and facilitating tissue healing, have further irritated and stimulated immune-mediated mechanisms that slowed down and prevented the healing process.Inmode performed investigation of the incident and the root cause was attributed to user error and additional factors not related to the device.The treatment with the morpheus8 was absolutely excessive and extremely aggressive.In addition, the healing was further delayed by aggressive procedures that followed the morpheus8 treatment.It is evident that the tissue repair process has undergone regressions and inflammatory flare-ups due to a multitude of therapeutic interventions which, instead of calming and facilitating tissue healing, have further irritated and stimulated immune-mediated mechanisms that slowed down and prevented the healing process.
Event or Problem Description
Pie on abdomen with tip footprints pattern 11 months after morpheus8 treatment.

• 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: 18048292
• Report Number: 3010511300-2023-00372
• Device Sequence Number: 7465596
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Notification,Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: AG609126A
• Device Catalogue Number: AG609126A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Race: White