BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURE LASER SYSTEM

    MDR report key: 18499883 · Received January 11, 2024

    Report

    Report Number
    3017786046-2024-00001
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    November 29, 2023
    Report Date
    January 11, 2024
    Manufacturer
    ACCURE ACNE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K222109
    Removal / Correction Number
    93696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SERVICE TECHNICIAN VISTIED THE SITE AND FOUND ONE OF THE FOUR TREATMENT LOCATIONS WAS DELIVERING HIGHER THAN EXPECTED POWER. THE REGION OF INTEREST (ROI) #4 WAS OUT OF POSITION AND NEEDED OT BE CORRECTED. ROI MISALIGNMENT WAS CAUSED BY EXCESSIVE HANDPIECE MOVEMENT.

    Description of Event or Problem · 0

    PT HAD A HISTAMINE REACTION OF BUMPS AFTER TREATMENT ON (B)(6) 2023 ON ONE SIDE OF HER FACE, BLISTERING OCCURRED AS WELL. PHOTOS UNRETRIEVABLE BUT PATIENT SPOKE WITH DOCTOR AND WAS PRESCRIBED HYDROCORTISONE CREAM AND ORAL ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828375 ACCURE LASER SYSTEM ACNE LASER GEX ACCURE ACNE, INC. PFMS00004

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention