MAUDE Adverse Event Report: IAGNES / AGNES RF USA,LLC. AGNES RF; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Damage to Ligament(s) (1952); Swelling/ Edema (4577)

Event Date 02/16/2021

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to agnes rf radiofrequency treatment.Patient stated that she received the agnes rf treatment on (b)(6) 2021 on her lower jaw line.Patient stated the device uses little needles to transmit the radiofrequency.Patient said she had swelling for two weeks after the treatment and then her entire middle cheek fell in.Patient stated where her cheek fell in, she did not receive any treatment in that area.Patient stated herself, and the doctor, believe a retaining ligament in her face must have been hit during the treatment.Patient stated that the treatment is not supposed to go that deep, but she also has a dent behind the treatment area on her low jaw line.Patient stated she told the company and initially they were responsive and agreed something had gone wrong with her treatment.However, the patient said they have gone silent and she's still waiting to hear back from a company physician.

• Brand Name: AGNES RF
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): IAGNES / AGNES RF USA,LLC.
• MDR Report Key: 11669858
• MDR Text Key: 245870676
• Report Number: MW5100794
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR