MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number AG607401A

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Erythema (1840)

Event Date 05/29/2022

Event Type  Injury  

Event Description

Residual pie in the shape of the tip footprints located in the lower abdomen one and a half year after treatment with morpheus8.

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.

• Brand Name: MORPHEUS8
• Type of Device: 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
• MDR Text Key: 324767143
• Report Number: 3010511300-2023-00232
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/03/2023

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
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other