MAUDE Adverse Event Report: INMODE LTD. BODYTITE; GEI

Model Number	AG604881A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient presents with neurapraxia of the upper lip following facetite procedure.Investigation is ongoing.
Event or Problem Description
Neuropraxia of upper lip.
Additional Manufacturer Narrative
Patient presents with neurapraxia of the upper lip following facetite procedure.Investigation is ongoing.04-aug-2024 follow-up narrative: the device could not be inspected as the customer is not responding to inmode's multiple attempts to contact her.The doctor is also not cooperating in filling the clinical form or scheduling a retraining.With the limited information available to inmode it was concluded that the reported neurapraxia was most probably caused by a user error: working in the "no fly zone", where the buccal branch of the facial nerve passes.The doctor was guided via e-mail regarding the user error and received recommendations for treating the patient.No additional information was received from the customer to this day.Nevertheless, the reported condition is expected to be transient.
Event or Problem Description
Neuropraxia of upper lip.

• Brand Name: BODYTITE
• 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: 19640779
• Report Number: 3010511300-2024-00565
• Device Sequence Number: 7400397
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Notification,Inspection,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2024

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: AG604881A
• Device Catalogue Number: AG606969A
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 08/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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 Race: White