MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erythema (1840); Hyperpigmentation (4837)
Date of Event	12/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient presents with pie and pih on her abdomen almost 8 months post morpheus8 treatment.Investigation is ongoing.
Event or Problem Description
Pie and pih on abdomen 8 months post morpheus8 treatment.
Additional Manufacturer Narrative
Female patient presents with pie and pih on her abdomen almost 8 months post morpheus8 treatment.Investigation is ongoing.(b)(6) 2024: follow up report is submitted with investigation conclusions.The device was not inspected as the clinic confirmed they have been using the device without any issues and this is an isolated incident.The investigation concluded that the prolonged pie/pih were a result of delayed healing due to several factors.First, the initial inflammatory response could have been triggered by application of a numbing cream with high percentage of anesthetics and patient's individual hypersensitivity.The healing in general is usually delayed in such peripheral areas, especially with increased skin laxity such as of this patient, since such skin has poorer circulatory efficiency.However, the healing was perturbed further by multiple additional procedures done by the provider after morpheus8 treatment: application of a cream containing multiple active substances interfering with the healing process, ipl treatment, and three fractional thulium laser treatments.All this contributed to inflammation, interfered with the normal healing process and led to the observed pie/pih.
Event or Problem Description
Pie and pih on abdomen 8 months post 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: 20188834
• Report Number: 3010511300-2024-00617
• Device Sequence Number: 20597665
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Patient Monitoring,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2024

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: AG609126A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/29/2024
• 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): Yes
• 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: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White