MAUDE Adverse Event Report: INMODE LTD BODYTITE; FACETITE

Model Number AG604881A

Device Problem Use of Device Problem (1670)

Patient Problem Movement Disorder (4412)

Event Date 02/11/2021

Event Type  Injury  

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 Description

Evident neurapraxia in the right lower lip after a facetite treatment on (b)(6) 2021.

Manufacturer Narrative

Follow up report 07/05/2023: 1.H6 health effect - impact code - changed to 4619.2.D4 added udi number.

Event Description

Evident neurapraxia in the right lower lip after a facetite treatment on (b)(6) 2021.

• Brand Name: BODYTITE
• Type of Device: 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
• MDR Text Key: 309750620
• Report Number: 3010511300-2023-00036
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White