MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Erythema (1840); Hyperpigmentation (4837)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient complained to inmode about having pie/pih over her face 9 months post morpheus 8 treatment.During the investigation it was revealed that the treatment provider is not an inmode customer and did not undergo a training by inmode.Treatment settings utilized by the provider were not in congruence with the recommended protocol.According to the patient, she was also recommended by the provider to apply vitamin c serum post treatment, which contributed to the inflammation and delayed the healing.Additionally, the patient underwent laser treatments at a different clinic after morpheus8 procedure on the skin that has not healed yet, promoting the inflammatory process.All these factors contributed to the delayed healing and the reported condition.
Event or Problem Description
Pih/pie over face 9 months post morpheus 8 treatment.
Event or Problem Description
Pih/pie over face 9 months post morpheus8 treatment.
Additional Manufacturer Narrative
The patient complained to inmode about having pie/pih over her face 9 months post morpheus8 treatment.During the investigation it was revealed that the treatment provider is not an inmode customer and did not undergo a training by inmode.Treatment settings utilized by the provider were not in congruence with the recommended protocol.According to the patient, she was also recommended by the provider to apply vitamin c serum post treatment, which contributed to the inflammation and delayed the healing.Additionally, the patient underwent laser treatments at a different clinic after morpheus8 procedure on the skin that has not healed yet, promoting the inflammatory process.All these factors contributed to the delayed healing and the reported condition.19-nov-2024: follow-up report is submitted with additional information and correction.D4- serial number was corrected.The provider has been established as inmode customer and received an official training by inmode.The device was inspected 1 year after the incident.The technical issue revealed during technical inspection was concluded to be not related to the incident, based on provider's confirmation that since the incident in (b)(6) 2023 hundreds of patients have been treated with no issues.Investigation concluded the root cause to be the incorrect treatment protocol utilized by the provider and multiple additional aggressive procedures and substances applied post treatment, which perturbed the normal healing process.

• 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: 19788610
• Report Number: 3010511300-2024-00574
• Device Sequence Number: 20929938
• 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: Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/21/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2020
• 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