MAUDE Adverse Event Report: INMODE LTD. FRACTORA; GEI

Model Number AG601261A

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2017

Event Type  Injury  

Event Description

This complaint was initially reported by the patient directly to fda on (b)(6) 2020 (mw5097418) and stated " 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).".

Manufacturer Narrative

Since no contact details are available, inmode could not perform investigation and further assess this event.Up to date we couldn't retrieve any information at all regarding this patient's report.Therefore this report is based exclusively on the patient's narrative.As part of a capa opened internaly in inmode that includes a retrospective review of patients' complaints reported in maude, this complaint was assessed as serious and hence is reported.

• Brand Name: FRACTORA
• Type of Device: GEI
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17628884
• MDR Text Key: 322019832
• Report Number: 3010511300-2023-00316
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07290016633054
• UDI-Public: 07290016633054
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AG601261A
• Device Catalogue Number: AG601261A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 08/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other