BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMELIGHT

    MDR report key: 19652586 · Received July 1, 2024

    Report

    Report Number
    2954354-2024-00009
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    September 10, 2024
    Manufacturer
    CUTERA, INC.
    Product Code
    ILY
    UDI-DI
    00816722022110
    PMA / PMN Number
    K050047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP TO THE INITIAL EMDR FILED ON 01-JUL-2024. AS REPORTED INITIALLY, THE LIMELIGHT PULSED LIGHT HANDPIECE WAS UTILIZED IN A MEDICAL PROCEDURE ON (B)(6) 2024 TO TREAT THE ANTERIOR ASPECTS OF BOTH THE UPPER AND LOWER LEGS, BILATERALLY. THE PRIMARY OBJECTIVE OF THIS INTERVENTION WAS THE MITIGATION OF BENIGN PIGMENTED LESIONS. POST PROCEDURE, THE PATIENT EXHIBITED SYMPTOMS OF SUPERFICIAL EPIDERMAL AND SUPERFICIAL PARTIAL THICKNESS BURNS. THE DERMAL INJURIES WERE TREATED WITH STEM CELL TREATMENT, IN CONJUNCTION WITH THE APPLICATION OF TOPICAL OINTMENTS EUCERIN AND AQUAPHOR. THE MEDICAL INSTITUTION HAS NOT RESPONDED TO CUTERA'S REQUESTS FOR SPECIFIC DETAILS PERTAINING TO THE PATIENT, THE TREATMENT PROTOCOL, AND THE SUBSEQUENT OUTCOME. SINCE THE INITIAL EMDR, THE DEVICE WAS EVALUATED BY A CUTERA FSE AND WAS FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    THE LIMELIGHT PULSED LIGHT HANDPIECE WAS UTILIZED IN A MEDICAL PROCEDURE TREATING THE ANTERIOR ASPECTS OF BOTH THE UPPER AND LOWER LEGS, BILATERALLY. THE PRIMARY OBJECTIVE OF THIS INTERVENTION WAS THE MITIGATION OF BENIGN PIGMENTED LESIONS. POST PROCEDURE, THE PATIENT EXHIBITED SYMPTOMS OF SUPERFICIAL EPIDERMAL AND SUPERFICIAL PARTIAL THICKNESS BURNS. THESE DERMAL INJURIES ARE CURRENTLY UNDERGOING A TREATMENT REGIMEN THAT INCLUDES "STEM CELL TREATMENT", IN CONJUNCTION WITH THE APPLICATION OF TOPICAL OINTMENTS EUCERIN AND AQUAPHOR. THE MEDICAL INSTITUTION HAS NOT RESPONDED TO CUTERA'S REQUESTS FOR SPECIFIC DETAILS PERTAINING TO THE PATIENT, THE TREATMENT PROTOCOL, AND THE SUBSEQUENT OUTCOME. THERE IS NOT A DEVICE PERFORMANCE COMPLAINT ASSOCIATED WITH THIS CLINICAL CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508293 LIMELIGHT PULSED LIGHT HANDPIECE ILY CUTERA, INC. 00816722022110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other