MAUDE Adverse Event Report: INMODE LTD. EMBODYPLUS (TITE) APPLICATOR

Model Number	AG608083A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No technical issues were identified upon device inspection.The operator used treatment settings congruent with our recommended protocol.The root cause was attributed to focal lack of coupling gel or incomplete contact due to patient moving.Additionally, the fibrotic tissue of the scar on which the electrodes were placed also contributed to the thermal damage due to inefficient dissipation of the heat in the fibrotic tissue compared to healthy skin.The clinic was reiterated on the importance of sufficient amounts of coupling gel and maintaining full contact throughout the treatment.
Event or Problem Description
A female patient presenting with a roundish full thickness burn of approximately 1.5cm in diameter on her lower abdomen following treatment with tite applicator.The burn is situated in the center of a pre-existing scar that vertically crosses the lower abdomen, going from the navel downwards.

• Brand Name: EMBODYPLUS (TITE) APPLICATOR
• Common Device Name: EMBODYPLUS (TITE) APPLICATOR
• 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: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 23603788
• Report Number: 3010511300-2025-00971
• Device Sequence Number: 21144630
• Product Code: PBX
• UDI-Device Identifier: 07290016633511
• UDI-Public: 07290016633511
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Notification,Patient Monitoring,Inspection
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: AG608083A
• Device Catalogue Number: AG608083A
• Device Lot Number: 22-03; 21-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Race: White