BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 18419574 · Received December 29, 2023

    Report

    Report Number
    1222993-2023-00019
    Event Type
    Injury
    Date Received
    December 29, 2023
    Report Date
    December 29, 2023
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING S.P.A
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED A BURN FOLLOWING A TREATMENT USING SMARTXIDE2. CYNOSURE CLINICAL INVESTIGATED THE INCIDENT AND DETERMINED THAT USER ERROR WAS INVOLVED. OPERATOR DID NOT PERFORM RF EMITTANCE TREATMENT WITH FULL CONTACT ON TISSUE AND THEREFORE LIKELY CONTRIBUTED TO BURN EXPERIENCED. BURN WAS EXAMINED BY CYNOSURE MEDICAL DIRECTOR WHO CONFIRMED PATIENT HAS FULL THICKNESS INJURY WITH PERMANENT SCARRING LIKELY. A SERVICE EVALUATION HAS BEEN SCHEDULED BUT NOT YET COMPLETED. WHEN THE DEVICE HAS BEEN EVALUATED, AN INVESTIGATION WILL BE UPDATED AS NEEDED. BURNS ARE EXPECTED SIDE EFFECTS FROM SUCH TREATMENTS, HOWEVER THIS EVENT IS REPORTABLE BECAUSE SCARRING IS CONSIDERED A SERIOUS PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842213 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL. EN. ELECTRONIC ENGINEERING S.P.A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability| O