MAUDE Adverse Event Report: INMODE LTD. EVOLVE SYSTEM WITH TRANSFORM APPLICATOR

Model Number	AG608081A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A doctor reported of a small (less than 1cm) third degree burn on her buttock following treatment with transform applicator that took place 1.5 years ago.Up to date, no photos nor clinical form have been provided to inmode to enable clinical assessment of this alleged adverse event.Technical issue identified during service inspection was excluded as possible cause of a burn.Due to lack of information and cooperation from doctor's side, we cannot establish the root cause of this alleged event.Nevertheless, it was decided to report this incident out of "abundance of caution".
Event or Problem Description
Alleged third degree burn and scarring on buttock following treatment with the transform applicator.
Additional Manufacturer Narrative
A doctor reported of a small (less than 1cm) third degree burn on her buttock following treatment with transform applicator that took place 1.5 years ago.Up to date, no photos nor clinical form have been provided to inmode to enable clinical assessment of this alleged adverse event.Technical issue identified during service inspection was excluded as possible cause of a burn.Due to lack of information and cooperation from doctor's side, we cannot establish the root cause of this alleged event.Nevertheless, it was decided to report this incident out of "abundance of caution".(b)(6) 2025: fu report is submitted with the following corrections/updates: patient's race a6 corrected.Event date b3 corrected patient's age added.Inmode received photos and a clinical form from the doctor.Following clinical assessment of the photos, the burn was assessed to be of partial thickness, and therefore it was decided to downgrade the report to non-serious.Such small and superficial lesion is expected to heal with only a possibility of some trivial cosmetic damage.As technical issue identified during service inspection was excluded as a possible cause of the burn, investigation attributed the root-cause to focal lack of coupling gel or incomplete contact of the applicator with the skin.
Event or Problem Description
Second degree burn on buttock following treatment with the transform applicator.

• Brand Name: EVOLVE SYSTEM WITH TRANSFORM APPLICATOR
• Common Device Name: EVOLVE SYSTEM WITH TRANSFORM 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: 22024215
• Report Number: 3010511300-2025-00820
• Device Sequence Number: 13036382
• Product Code: IPF
• UDI-Device Identifier: 07290016633498
• UDI-Public: 07290016633498
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: AG608081A
• Device Catalogue Number: AG608081A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian