MAUDE Adverse Event Report: INMODE LTD. BODYTITE; GEI

Model Number	AG604881A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hard purplish nodule on left thigh in a female patient treated with bodytite bilaterally in (b)(6) 2022 for skin laxity.
Additional Manufacturer Narrative
Initially, the incident was assessed as a trivial cosmetic damage.Further investigation concluded that the reported nodule is most probably a keloid scar formed as a result of a burn caused by incorrect technique of the doctor who performed the procedure.Later evaluation confirmed that excision should be performed and the case was upgraded to serious.
Additional Manufacturer Narrative
17-apr-2024 - follow up report is submitted to correct the following information: brand name, model number, catalogue number, udi number, 510k number.Initially, the incident was assessed as a trivial cosmetic damage.Further investigation concluded that the reported nodule is most probably a keloid scar formed as a result of a burn caused by incorrect technique of the doctor who performed the procedure.Later evaluation confirmed that excision should be performed and the case was upgraded to serious.
Event or Problem Description
Hard purplish nodule on left thigh in a female patient treated with bodytite bilaterally in (b)(6) 2022 for skin laxity.

• Brand Name: BODYTITE
• Common Device Name: GEI
• 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: 18985014
• Report Number: 3010511300-2024-00429
• Device Sequence Number: 20934000
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Notification,Other,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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: AG604881A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White