MAUDE Adverse Event Report: INMODE LTD. BODYTITE INMODE RF SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	HP101306A
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	06/18/2018
Event or Problem Description
Pt emailed mfr directly from pt inquiry from on company's website stating she has burns on legs from bodytite treatment and to contact her.Fda safety report id# (b)(4).

• Brand Name: BODYTITE INMODE RF SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.
• MDR Report Key: 9817947
• Report Number: MW5093653
• Device Sequence Number: 3534858
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: No Information
• Type of Report: Initial
• Report Date (Section B): 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HP101306A
• Device Catalogue Number: HP101306A
• Device Lot Number: 18-09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1