BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURE ACNE LASER SYSTEM

    MDR report key: 20707956 · Received November 15, 2024

    Report

    Report Number
    MW5162580
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    July 1, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ACCURE ACNE, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    505
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 I WAS ACTING AS THE INSTALLATION TECHNICIAN FOR ACCURE ACNE, A LASER DISTRIBUTOR FOR THE ACCURE LASER BUILT BY QUANTA SYSTEM. THE PROCEDURE REQUIRED THAT I TEST FIRED THE LASER AFTER CALIBRATION ON MY ARM. THIS WAS A NEW PROCEDURE, AND THE PREVIOUS PROCEDURE THAT REQUIRED TESTING ON THE TECHNICIAN'S ARM HAD A MAX OF 40C. THE NEW PROCEDURE REQUIRED 45C. I TOOK THE FIRST SHOT, AND IT CAME IN AT 50C. I TOOK 4 MORE SHOTS AROUND MY LEFT ARM FOR AN AVERAGE TREATMENT TEMPERATURE OF 45C, WHICH MEANT THE TEST PASSED. IT HAS BEEN 4 MONTHS AND THE SPOT WHERE THE INITIAL BURN OCCURRED SHOWS A DARK MARK IN THE TYPICAL BURN PATTERN OF THE ACCURE LASER. I HAVE DOCUMENTED THE MARK AND HOW IT HAS CHANGED OVER THE PAST 4 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609295 ACCURE ACNE LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX ACCURE ACNE, INC. PFMS00004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other