MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM FACE TITE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number HP1010306A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Neuropathy (1983); Neuralgia (4413)

Event Date 02/11/2021

Event Type  Injury  

Event Description

Patient right side of mouth sagging post facetite treatment.Evident neurapraxia in the right lower lip after a facetite treatment on february 11th.Based on our past experience, in such cases, the nature of the injury is almost always transient.Doctor (b)(6) refuses to collaborate with our representatives and would not fill in the ccq, neither accept a technical inspection of the system.Manufacturer case investigation: furthermore, he has announced that he no longer intends to use this technology.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 a mechanical user error related to an incorrect maneuver of the cannula in the area of the path of the marginal mandibular nerve.Fda safety report id # (b)(4).

• Brand Name: INMODE RF SYSTEM FACE TITE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.; yokneam iillit 20692 06 I; IS 2069206 IL
• MDR Report Key: 12188979
• MDR Text Key: 262434926
• Report Number: MW5102617
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 17290016633211
• UDI-Public: 17290016633211
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HP1010306A
• Device Catalogue Number: HP1010306A
• Device Lot Number: 20-44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1