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

Model Number HP101306A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn, Thermal (2530)

Event Date 06/18/2018

Event Type  No Answer Provided  

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.
• MDR Report Key: 9817947
• MDR Text Key: 183295713
• Report Number: MW5093653
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: HP101306A
• Device Catalogue Number: HP101306A
• Device Lot Number: 18-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1