MAUDE Adverse Event Report: INMODE LTD. FRACTORA; GEI

Model Number AG601261A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Scar Tissue (2060); Skin Infection (4544)

Event Date 08/11/2018

Event Type  Injury  

Manufacturer Narrative

Following internal capa opened at inmode, voluntary reports previously submitted by inmode to fda were reviewed retrospectively.Previous voluntary report (mw5092685) was re-assessed and is reported now again as mandatory.Technical inspection of the device and the handpiece revealed no technical issues.Investigation attributed the root cause to a user error: incorrect technique, not congruent with ifu, causing the burns.Contamination was due to lack of aseptic conditions post treatment and is not related to the device.The physician was retrained.

Event Description

Burns on face with subsequent contamination.Residual indentations 3 months post treatment.

• 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: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 17648619
• MDR Text Key: 322244439
• Report Number: 3010511300-2018-00821
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07290016633054
• UDI-Public: 07290016633054
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AG601261A
• Device Catalogue Number: AG601261A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White