MAUDE Adverse Event Report: INMODE LTD. TRANSFORM (T3 APPLICATOR); PBX

Model Number	AG609899A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A male patient presented with a full thickness burn of ~2cm in diameter on his lower abdomen following treatment with the transform applicator.Investigation is ongoing.
Event or Problem Description
Full thickness burn on abdomen post transform treatment.
Event or Problem Description
Full thickness burn on abdomen post transform treatment.
Additional Manufacturer Narrative
A male patient presented with a full thickness burn of ~2cm in diameter on his lower abdomen following treatment with the transform applicator.Investigation is ongoing.13-aug-2025: a follow-up report is submitted with investigation conclusions.Technical inspection of the device revealed a technical issue (high resistance measure) that was determined to be not related to the reported burn.Investigation attributed the root-cause to a user error: the applicator was re-positioned following its positioning on the abdomen, without applying sufficient amount of coupling gel, leading to focal hot spot.The clinic has received a re-training and the patient has completely healed.

• Brand Name: TRANSFORM (T3 APPLICATOR)
• Common Device Name: PBX
• 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: 22304429
• Report Number: 3010511300-2025-00863
• Device Sequence Number: 8017125
• Product Code: PBX
• UDI-Device Identifier: 07290016633689
• UDI-Public: 07290016633689
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other,Patient Monitoring,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: AG609899A
• Device Catalogue Number: AG609899A
• Device Lot Number: 23-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/22/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Race: White