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 Codes	Erythema (1840); Hyperpigmentation (4837)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation conclusion: user error: energy levels used were too high, not congruent with the recommended settings.Addition of extra pass at 3mm depth.Test spot was not done.Patient applied post tx active products which could have compromised the healing process.Plus, individual hypersensitivity, which could have been observed if test spot would have been performed as required.
Event or Problem Description
Pie on abdomen 1 year post 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: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17593612
• Report Number: 3010511300-2023-00292
• Device Sequence Number: 8876915
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Other,Notification
• Type of Report: Initial
• Report Date (Section B): 08/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2021
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White