BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MD

    MDR report key: 19634716 · Received June 28, 2024

    Report

    Report Number
    1222993-2024-00033
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 28, 2024
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K141425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A DEVICE EVALUATION, TECHNICIAN CONFIRMED THAT THE ENERGY WAS LOW AND GREATER THAN 20% OUTSIDE OF SPECIFICATION. ROOT CAUSE FOR PATIENT'S SYMPTOMS ARE UNKNOWN. THERE WAS NO CONFIRMATION THAT IT WAS RELATED TO TREATMENT NOR DEVICE MALFUNCTION. SITE HAD REPORTED THAT PATIENT'S SYMPTOMS RESOLVED 24 HOURS POST TREATMENT WITHOUT INTERVENTION. REPLACEMENT PARTS WERE ORDERED TO RESOLVE THE ISSUE. THIS INCIDENT IS REPORTABLE BECAUSE IT IS AN ACCIDENTAL RADIATION OCCURRENCE (ARO) SINCE THE DEVICE OPERATED OUT OF SPECIFICATION RANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED AN ABUNDANCE OF WHITE HEADS FOLLOWING A LASER HAIR REDUCTION TREATMENT ON THE FACE USING ELITE MD. FIRST PATIENT WAS REPORTED IN MDR# 1222993-2024-00032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787019 ELITE MD ELITE MD GEX CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female