MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	05/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Residual pie in the shape of the tip footprints located in the lower abdomen one and a half year after treatment with morpheus8.
Additional Manufacturer Narrative
Initially, the clinic provided photos of a patient with abdomen in a postpartum phase presenting multiple stretch marks and poor laxity, with residual erythematous tip footprints in the lower region.Based on the pictures of 5 months post treatment, it appears that the procedure was done in the beginning of the pregnancy, although pregnancy is listed as contraindication for morpheus8 treatment in ifu.The initial immune reaction could have been triggered by the application of a numbing cream with high percentage of anesthetics combined with aggressive treatment parameters (burst mode with too many passes).The healing was delayed both due to the peripheric treatment region and the fact that during pregnancy the skin undergoes mechanical stress and healing mechanisms are perturbed.Initially, inmode decided to monitor patient's healing progress as full resolution was expected despite the delayed timing.However, recently additional information was received from the provider upon inmode's attempt to inquire on patient's status, stating the patient hasn't resolved.Therefore, it was decided to report the incident due to longevity of the adverse event.Nevertheless, a gradual and continuous improvement of the skin texture as well as normalization and healing of the micro-lesions are expected.
Event or Problem Description
Residual pie in the shape of the tip footprints located in the lower abdomen one and a half year after treatment with morpheus8.
Additional Manufacturer Narrative
02-nov-2025: follow-up report is submitted to correct the date received by manufacturer to 05-sep-2023.Initially, the clinic provided photos of a patient with abdomen in a postpartum phase presenting multiple stretch marks and poor laxity, with residual erythematous tip footprints in the lower region.Based on the pictures of 5 months post treatment, it appears that the procedure was done in the beginning of the pregnancy, although pregnancy is listed as contraindication for morpheus8 treatment in ifu.The initial immune reaction could have been triggered by the application of a numbing cream with high percentage of anesthetics combined with aggressive treatment parameters (burst mode with too many passes).The healing was delayed both due to the peripheric treatment region and the fact that during pregnancy the skin undergoes mechanical stress and healing mechanisms are perturbed.Initially, inmode decided to monitor patient's healing progress as full resolution was expected despite the delayed timing.However, recently additional information was received from the provider upon inmode's attempt to inquire on patient's status, stating the patient hasn't resolved.Therefore, it was decided to report the incident due to longevity of the adverse event.Nevertheless, a gradual and continuous improvement of the skin texture as well as normalization and healing of the micro-lesions are expected.

• 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: 17859176
• Report Number: 3010511300-2023-00232
• Device Sequence Number: 20352030
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K192695
• 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: Administrator/Supervisor
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2025

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
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2020
• 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: Unknown