BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILIFT

    MDR report key: 17804948 · Received September 23, 2023

    Report

    Report Number
    3020611964-2023-00013
    Event Type
    Injury
    Date Received
    September 23, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 23, 2023
    Manufacturer
    POLLOGEN LTD
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294576 TRILIFT STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX POLLOGEN LTD TRILIFT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other