MAUDE Adverse Event Report: POLLOGEN LTD TRILIFT; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number TRILIFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 08/25/2023

Event Type  Injury  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly.Attempts by emails and phone calls have been made to obtain; patient treatment settings, patient information and patient photo.No incident form or patient photo has been received in lumenis.This case was escalated to tech.Support team.According to tech.Support team, the customer didn't use the correct treatment cream that recommended by lumenis and there was no malfunction with the tripolar handpiece.The customer should use chem world glycerin cream instead of cvs glycerin cream.It was clarified to the customer why the chem world glycerin cream is recommended and also the best practice of using smaller dispenser sizes and limiting exposure to air.The device was installed on january 04, 2023 and still under warranty.Clinical evaluation wasn't performed, since no incident form or patient photos were sent to lumenis.While the information received to date does not confirm that a serious injury nor malfunction had occurred, because of the lack of information lumenis is reporting the event in an 'abundance of caution'.Should additional significant information become available, the complaint record will be updated accordingly, and a follow-up medwatch report will be submitted.Lumenis is not the manufacturer of the trilift device which was used during this procedure, lumenis has forwarded the information of this event to the legal manufacturer and is closing this complaint.

Event Description

Lumenis received an adverse event report on two patients who sustained burn marks using tripolar handpiece following treatment by trilift device.Since lumenis didn't receive incident form from the customer, this complaint represents both patients.

• Brand Name: TRILIFT
• Type of Device: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): POLLOGEN LTD; 6 kaufman st.; tel aviv, israel 68012 98; IS 6801298
• MDR Report Key: 17804948
• MDR Text Key: 324117429
• Report Number: 3020611964-2023-00013
• Device Sequence Number: 1
• Product Code: NGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/23/2023

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 Operator: Other
• Device Model Number: TRILIFT
• Device Catalogue Number: 30020000BK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2023
• Distributor Facility Aware Date: 08/25/2023
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other