MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number AG609126A

Device Problem Insufficient Information (3190)

Patient Problem Erythema (1840)

Event Date 03/06/2023

Event Type  Injury  

Event Description

Pie with tip footprint pattern on both anterior thighs 6 months after morheus8 treatment.

Manufacturer Narrative

The investigation was performed using the limited information available to inmode as the customer refused to fill the clinical questionnaire.The observed post-inflammatory reaction is most probably a result of relatively aggressive treatment settings for the chosen treatment area.Additionally, the healing may be delayed in such peripheral areas.Despite the superficial nature of the observed condition, inmode decided to report it due to longevity of the reaction.Nevertheless, it is expected to fully resolve with time.

• 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: 18098938
• MDR Text Key: 327698365
• Report Number: 3010511300-2023-00367
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG609126A
• Device Catalogue Number: AG609126A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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
• Patient Sex: Female