MAUDE Adverse Event Report: INMODE LTD. BODYTITE; GEI

Model Number AG604881A

Device Problem Use of Device Problem (1670)

Patient Problem Scar Tissue (2060)

Event Date 12/14/2022

Event Type  Injury  

Event Description

Hard purplish nodule on left thigh in a female patient treated with bodytite bilaterally in (b)(6) 2022 for skin laxity.

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.

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 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
• Type of Device: 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
• MDR Text Key: 338659695
• Report Number: 3010511300-2024-00429
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG604881A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White