BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURE LASER SYSTEM

    MDR report key: 17741238 · Received September 13, 2023

    Report

    Report Number
    3017786046-2023-00003
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 13, 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
    117

    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. IN ADDITION, PURACYN PLUS ANTIMICROBIAL SOLUTION WAS APPLIED PRIOR TO LASER ENERGY APPLICATION. THE ROI MISALIGNMENT CREATED A HIGHER-THAN-EXPECTED POWER RESULTING IN THE BLISTERING. THE ADDITION OF PURACYN PLUS AND 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 BLISTERING WITHIN 12 HOURS AFTER TREATMENT. AT THE FOLLOW UP VISIT, ABOUT THREE WEEKS LATER, THE PATIENT PRESENTED WITH SCARRING. THE PROVIDER AT THE TIME OF TREATMENT PRESCRIBED THE PATIENT ORAL AND TOPICAL ANTIBIOTICS, AND TOPICAL STEROID, AND AT THE FOLLOW-UP VISIT RESTARTED RETINOID TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88317 ACCURE LASER SYSTEM ACNE LASER GEX ACCURE ACNE, INC. PFMS00004

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention