BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURE LASER SYSTEM

    MDR report key: 17716007 · Received September 8, 2023

    Report

    Report Number
    3017786046-2023-00001
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 11, 2023
    Report Date
    September 8, 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 THE UNIT TO BE OPERATING PER SPECIFICATION. FOLLOW-UP INFORMATION INDICATED THAT PURACYN PLUS ANTIMICROBIAL SOLUTION WAS APPLIED PRIOR TO LASER ENERGY APPLICATION. PURACYN PLUS APPEARS TO BE A CONTRIBUTING FACTOR TO LOCALIZED THERMAL ABSORPTION OF ENERGY.

    Description of Event or Problem · 0

    ACCURE WAS NOTIFIED BY A PROVIDER THAT THEY NOTICED ONE SPOT APPEARED TOO HOT SO THEREFORE REQUESTED SERVICE OF THE DEVICE. THE PROVIDER THEN CONTACTED ACCURE THREE DAYS LATER STATING THE PATIENT CALLED TO REPORT BLISTERS AND DIVOTS IN HER SKIN. RUPTURED BLISTERS WITH CRUST WERE OBSERVED AT A FOLLOW-UP VISIT AND ORAL AND TOPICAL ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127745 ACCURE LASER SYSTEM ACNE LASER GEX ACCURE ACNE, INC. PFMS00004

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention