MAUDE Adverse Event Report: INMODE LTD MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Localized Skin Lesion (4542)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The described lesions are atypical for the frf technology (morpheus8) used during this treatment, usually characterized by different patterns.Under investigation.
Event or Problem Description
3 ulcerative lesions 3 weeks following m8 body tx, one of which about 2 cm in diameter located in the medial aspect of the left thigh.Crust formation and inflamed contours are observed.2 other smaller ulcerative lesions, each about 1 cm in diameter, located respectively on the medial aspect of the right thigh.Also here, eschar formations and inflamed (possibly infected) contours are observed.The lesions present ulcerative craters, apparently quite deep with involvement of the dermal reticular tissue.Fibrotic scarring cannot be ruled out at the moment.

• 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: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17150332
• Report Number: 3010511300-2023-00263
• Device Sequence Number: 11745107
• 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: K221571
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 06/19/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White