MAUDE Adverse Event Report: INMODE LTD BODYTITE; FACETITE

Model Number	AG606972A
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A tissue necrosis in the suprapubic region (mons) following a reduction treatment with bodytite.Suspicious for erysipelas as the underlying tissue blanched few days after.A week later, the wounds evolved and pseudoeschar was seen.In the last photo there is significant straw-colored drainage, possibly a small seroma draining from a full thickness wound.
Additional Manufacturer Narrative
User error: excessive quantity of energy was delivered (25.2kj) in relatively small area (suprapubic area- mons).This energy surplus, transforming into heat, was irradiated with a retarding effect towards the dermal tissue, causing burns and tissue necrosis.A subsequent secondary infection cannot be ruled out.Summary of related investigations an excessive amount of energy generated an accumulated surplus of heat which evolved into trans skin burn with necrotic outcome and possibly a secondary infection (erysipelas).
Additional Manufacturer Narrative
Follow up report 07/05/2023.1.H6.Health effect - impact code - changed to 4619.Medical device problem code - changed to 1126.Investigation findingscode - changed to 4248.Investigation conclusion code - changed to 61.2.H11.Attached: upon arrival test.Final test.In service report (retrain).
Event or Problem Description
A tissue necrosis in the suprapubic region (mons) following a reduction treatment with bodytite.Suspicious for erysipelas as the underlying tissue blanched few days after.A week later, the wounds evolved and pseudoeschar was seen.In the last photo there is significant straw-colored drainage, possibly a small seroma draining from a full thickness wound.

• Brand Name: BODYTITE
• Common Device Name: FACETITE
• 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: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 16395050
• Report Number: 3010511300-2023-00067
• Device Sequence Number: 6385110
• Product Code: GEI
• UDI-Device Identifier: 17290016633211
• UDI-Public: 17290016633211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: AG606972A
• Device Catalogue Number: AG606972A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic
• Patient Race: White