MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inmode is performing attempts to contact the patient to obtain additional information and to indetify the provider.
Event or Problem Description
This complaint was initially reported by the patient directly to fda on 04-jan-2023 (mw5114225) and stated: "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.".
Event or Problem Description
This complaint was initially reported by the patient directly to fda on 04-jan-2023 (mw5114225) and stated: "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.".
Additional Manufacturer Narrative
Based on the information provided by the treatment provider, event date was corrected to 2022, and not 2021 as initially reported by the patient to fda.This means that the patient reported the alleged adverse events to fda 1 year post treatment, and not 2 years.The treatment date was also confirmed by patient's posts on a social network.Inmode performed investigation and the reported adverse events could not be confirmed.The event was downgraded to non serious.Five months post tx the patient complained to the provider about fat loss under her eyes, but on the fu visit the provider actually noted reduction of fine lines under her eyes and documented "skin looked great".This indeed is seen on the provided photos.Later, patient received botox injections, which affected the eyebrows position, as confirmed by the treatment provider.Treatment settings with morpheus8 in the periorbital area were not aggressive and were within the recommended limits.Eight months post tx the provider could not detect the alleged problem.Regarding head pain that the patient reported in her complaint to fda: she posted later on social network "my brain mri came back normal".To conclude, the alleged adverse events could not be corroborated neither by the photos, nor by the treatment provider.

• 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: 17640344
• Report Number: 3010511300-2023-00321
• Device Sequence Number: 14850561
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K210492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2023

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: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White