MAUDE Adverse Event Report: INMODE LTD. ELECTROSURGICAL RF DEVICE EVOKE RIGHT CHEEK APPLICATOR; MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT

Catalog Number	AG608275A
Health Effect - Clinical Codes	Full thickness (Third Degree) Burn (2696); Skin Burning Sensation (4540)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated with evoke system utilizing both the right and left cheek applicators.During the treatment time, the patient called for assistance and complaint of burned sensation in her right cheek.The healthcare team immediately stopped the device operation and had the patient hold ice to the area of the incident.Pictures of the patient treatment area revealed a round exposed burn about 2 cm in diameter, located at the skin portion in correspondence with the left tmj.Multi-layered transdermal damage with tissue necrosis was evident.The patient was sent for injury management and was under a care of a dermatologist for wound management and has been to a burn clinic.The device was returned to the manufacturer for testing and was shown to work safely under the required performance specifications, no device defects or malfunctions were detected.Fda safety report id # (b)(4).

• Brand Name: ELECTROSURGICAL RF DEVICE EVOKE RIGHT CHEEK APPLICATOR
• Common Device Name: MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT
• Manufacturer (Section D): INMODE LTD.; hokneam northern 20692 06 I; IS 2069206 IL
• MDR Report Key: 12228102
• Report Number: MW5102788
• Device Sequence Number: 4725378
• Product Code: PBX
• UDI-Device Identifier: 07290016633542
• UDI-Public: 07290016633542
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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 Catalogue Number: AG608275A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention