MAUDE Adverse Event Report: INMODE LTD. BODY TITE/FORMA INMODE RF SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION AND ACCESSORIES

Lot Number B64715604/H0620

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Type  No Answer Provided  

Event Description

Arcing feeling during the treatment over zygomatic bone area and mild burn appeared (from picture of pt) as a small red spot.A few months later dr reported that everything heated.Clinical specialist talked to clinic mgr and after looking the photos established that contact was lost over very curved over-bone area; user error.Company rep communicated to the dr, who stated that pt has healed.Fda safety report id# (b)(4).

• Brand Name: BODY TITE/FORMA INMODE RF SYSTEM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION AND ACCESSORIES
• Manufacturer (Section D): INMODE LTD. ; yokneam, il
• MDR Report Key: 9653602
• MDR Text Key: 177384829
• Report Number: MW5092656
• 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: Other
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: B64715604/H0620
• Is the Reporter a Health Professional?: No
• 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