MAUDE Adverse Event Report: INMODE LTD BODYTITE; FACETITE

Model Number	AG604881A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The neurapraxia that occurred in this event may have arisen from an involuntary impact of the instrument in the mandibular marginal nerve which in a certain point along the mandibular line protrudes in a superficial position.This results in a temporary neuropathy which usually resolves spontaneously within 2 - 3 months.It is therefore to be considered an error of the user who was unable to avoid the passage of the cannula in this area.Summary of related investigations mechanical user error related to an incorrect maneuver of the cannula in the area of the path of the marginal mandibular nerve, in contrary to the instructions given in our user manual.
Event or Problem Description
Evident neurapraxia in the right lower lip after a facetite treatment on (b)(6) 2021.
Additional Manufacturer Narrative
Follow up report 07/05/2023: 1.H6 health effect - impact code - changed to 4619.2.D4 added udi number.
Event or Problem Description
Evident neurapraxia in the right lower lip after a facetite treatment on (b)(6) 2021.

• Brand Name: BODYTITE
• Common Device Name: FACETITE
• 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: 16395171
• Report Number: 3010511300-2023-00036
• Device Sequence Number: 11536294
• Product Code: GEI
• UDI-Device Identifier: 17290016633211
• UDI-Public: 17290016633211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182325
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: AG604881A
• Device Catalogue Number: AG604881A
• Device Lot Number: HP101306A/22-40
• 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: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White