MAUDE Adverse Event Report: INMODE LTD. FRACTORA; GEI

Model Number	AG601261A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Event or Problem 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).".
Additional 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
• Common Device Name: 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
• Report Number: 3010511300-2023-00316
• Device Sequence Number: 7302233
• Product Code: GEI
• UDI-Device Identifier: 07290016633054
• UDI-Public: 07290016633054
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 08/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown