MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Prolonged pie on face following morpheus8 treatment.
Additional Manufacturer Narrative
A female patient complained to inmode about a prolonged pie reaction on her face following three morpheus8 treatments in the first quarter of 2022.At this point inmode is performing attempts to contact the treatment provider, but to no avail.Based on the limited information provided by the patient herself, it appears that the healing was delayed by patient's individual predisposition and by multiple aggressive procedures post morpheus8 treatments (such as multiple ipl sessions) which interfered with the regular healing process and contributed to the inflammation and the observed pie.Although improvement is seen in patient's condition relative to earlier photos, the case is reported due to the longevity of the reaction.Should additional information be received from the provider affecting the investigation conclusions, a follow-up report will be submitted.
Additional Manufacturer Narrative
A female patient complained to inmode about a prolonged pie reaction on her face following three morpheus8 treatments in the first quarter of 2022.At this point inmode is performing attempts to contact the treatment provider, but to no avail.Based on the limited information provided by the patient herself, it appears that the healing was delayed by patient's individual predisposition and by multiple aggressive procedures post morpheus8 treatments (such as multiple ipl sessions) which interfered with the regular healing process and contributed to the inflammation and the observed pie.Although improvement is seen in patient's condition relative to earlier photos, the case is reported due to the longevity of the reaction.Should additional information be received from the provider affecting the investigation conclusions, a follow-up report will be submitted.19-nov-2024: follow-up report is submitted with investigation conclusions.Inmode managed to contact the treatment provider.However, the treatment charts sent to inmode are lacking necessary information and did not shed any additional light on the root cause of the incident.The investigation conclusion remains the same: multiple ipls applied too early while the skin was still in the healing phase interfered with the normal healing process, prolonged the inflammation and led to the angiogenesis.
Event or Problem Description
Prolonged pie on face following 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: 20329762
• Report Number: 3010511300-2024-00604
• Device Sequence Number: 20802854
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Patient Monitoring,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White