BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUETTO MT

    MDR report key: 14110407 · Received April 14, 2022

    Report

    Report Number
    3004378299-2022-00065
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 14, 2022
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K192160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT CONCERNS A DEVICE NOT CLEARED IN THE US. ANYWAY, AS SIMILAR DEVICES OF THE SAME FAMILY ARE CLEARED UNDER K192160, WE DECIDED TO REPORT. DURING A HAIR REMOVAL TREATMENT A BURN ON THE PATIENT CHIN OCCURRED. WE ARE MONITORING THE ENTITY OF THE DAMAGE TO CHECK IF IT WOULD HEAL WITH COMMON MEDICAL TREATMENTS (CREAMS) WITH OR WITHOUT LEAVING A PERMANENT SCAR. THE CAUSE OF THE PRESENT EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    FACIAL BURN (COSMETIC IMPAIRMENT) DURING A HAIR REMOVAL TREATMENT NEAR THE CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256837 DUETTO MT AESTHETIC AND DERMATOLOGICAL LASER GEX QUANTA SYSTEM S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown