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

Model Number	AG609899A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Third degree burns on abdomen post transform treatment.
Additional Manufacturer Narrative
Patient presented with full thickness burns on the lower abdomen following treatment with transform applicator.Technical inspection of the device did not reveal any technical issues.Investigation concluded that the burns were caused by user errors: the operator started the treatment from the highest recommended temperature instead of starting from the lowest and increasing it gradually per ifu.Only after the patient complained of discomfort, the operator lowered the temperature.Most probably hot spots were formed due to focal lack of coupling gel, leading to the burns.Additionally, the coupling gel was not of a recommended brand.Retraining has been scheduled for the clinic.

• 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: 19640811
• Report Number: 3010511300-2024-00553
• Device Sequence Number: 17915496
• Product Code: PBX
• UDI-Device Identifier: 07290016633689
• UDI-Public: 07290016633689
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Other,Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 06/30/2024

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: 23-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Female
• Patient Race: White