MAUDE Adverse Event Report: INMODE LTD. BODYTITE FRACTORA / FORMA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Headache (1880); Burn, Thermal (2530); Patient Problem/Medical Problem (2688)

Event Date 10/07/2019

Event Type  No Answer Provided  

Event Description

Pt reports suffering burn, loss of facial fat and headaches post treatment.No info to back it up was given.There were no labels on hand piece.Hand piece was placed in quarantine for return to mfr.Fda safety report id# (b)(4).

• Brand Name: BODYTITE FRACTORA / FORMA
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD. ; yokneam 00206 92 I; IS 0020692 IL
• MDR Report Key: 9653565
• MDR Text Key: 177401482
• Report Number: MW5092654
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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