BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURE LASER SYSTEM

    MDR report key: 17821888 · Received September 26, 2023

    Report

    Report Number
    3017786046-2023-00005
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 26, 2023
    Manufacturer
    ACCURE ACNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K222109
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE TECHNICIAN VISITED THE SITE AND FOUND ONE OF FOUR TREATMENT LOCATIONS WAS DELIVERING HIGHER THAN EXPECTED POWER. THE REGION OF INTEREST (ROI) #4 WAS OUT OF POSITION AND HAD TO BE CORRECTED. ROI MISALIGNMENT WAS CAUSED BY EXCESSIVE HANDPIECE TIP MOVEMENT BY THE USER. FOLLOW-UP INFORMATION INDICATED THE PROVIDER DID NOT USE ALCOHOL AS THE FINAL STEP IN REMOVAL OF THE TOPICAL ANESTHETIC. THE PROVIDER ALSO UTILIZED HIGHER THAN RECOMMENDED SETTINGS FOR PEAK EPIDERMAL TEMPERATURE. THE ROI MISALIGNMENT CREATED A HIGHER-THAN-EXPECTED POWER RESULTING IN SCARRING. THE POSSIBLE INCOMPLETE REMOVAL OF THE TOPICAL ANESTHETIC CAN BE A CONTRIBUTING FACTOR TO LOCALIZED THERMAL ABSORPTION OF ENERGY.

    Description of Event or Problem · 0

    ACCURE WAS NOTIFIED BY A PROVIDER THAT A PATIENT EXHIBITED SCARRING AFTER TREATMENT. AT THE FOLLOW UP VISIT, ABOUT SIX WEEKS LATER, THE PATIENT PRESENTED WITH SCARRING. THE PROVIDER HAS DISCUSSED A COMBINATION TREATMENT UTILIZING AN ABLATIVE LASER AND FILLER TO TREAT THE SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724890 ACCURE LASER SYSTEM ACNE LASER GEX ACCURE ACNE, INC. PFMS00004

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention