MAUDE Adverse Event Report: INVASIX/INMODE LTD. FRACTORA RF MICRO-NEEDLING; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Scarring (2061); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2017

Event Type  Injury  

Event Description

I had fractora rf microneedling at my place of work.It resulted in scarring, fat loss and elasticity loss in my face.It also had a huge impact on me psychologically resulting in ptstd.Fda safety report id# (b)(4).

• Brand Name: FRACTORA RF MICRO-NEEDLING
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INVASIX/INMODE LTD.
• MDR Report Key: 10726074
• MDR Text Key: 213001803
• Report Number: MW5097418
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 58