BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 18066917 · Received November 3, 2023

    Report

    Report Number
    3001431138-2023-00010
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    July 2, 2020
    Report Date
    November 3, 2023
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133895
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE, THE MANUFACTURER OF THE DEVICE, VIA OUR US IMPORTER, CYNOSURE, PERFORMED THE INVESTIGATION BY CONTACTING THE PATIENT. CYNOSURE CONTACTED THE PATIENT AND FOUND OUT THE CLINIC WHERE THE TREATMENT WERE PERFORMED AND THE ACTUAL DEVICE INVOLVED IN THE EVENT. IN FACT THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN IDENTIFIED AS A DEKA SMARTXIDE2 WITH SERIAL NUMBER (B)(6) THAT IS MARKETED IN THE US WITH 510(K) NUMBER K133895. THE US IMPORTER INTERVIEWED THE PHYSICIAN OF THE CLINIC AND FOUND OUT THAT THE PHYSICIAN WHO PERFOMED THE TREATMENT, DR. S. TRUPIN, HAVE PERFORMED SEVERAL FOLLOW-UPS ON THE PATIENT DURING THE 4 YEARS SINCE THE FIRST MLT TREATMENT AND THAT THE PATIENT HAS NEVER MENTIONED THE COMPLICATION SHE REPORTED ON THE MW REPORT. MOREOVER IT IS NOT POSSIBILE TO DETERMINE IF THE COMPLICATION REPORTED BY THE PATIENT CAN BE RELATED TO THE MONALISA TOUCH TREATMENT OR IF IT IS RELATED TO THE CONTRACEPTIVE INJECTIONS THE PATIENT USES. THE EVENT TOOK PLACE AT HADA COSMETIC MEDICINE LLC CLINIC PLACED AT 212 S. NEIL ST, CHAMPAIGN, IL - USA. THE ACTUAL DEVICE INVOLVED IN THE EVENT WAS CHECKED, HAS NOT BEEN CHECKED DUE TO THE FCAT THAT MORE THAN 3 YEARS HAS PASSED SINCE THE DATE OF THE EVENT (AS REPORTED BY THE PATIENT ON THE MW REPORT) AND BECAUSE THE USER NEVERE REPORTED OF DEVICE'S FAILURES AND/OR ALARM THAT AROSE IN THIS YEARS. THE USER KEPT USING THE DEVICE NORMALLY WITHOUT ANY ISSUE. NO REMEDIAL ACTION REQUIRED - INVESTIGATION ON THE EVENT RESULTED IMPOSSIBLE, BASED ON THE AVAILABLE INFORMATION. ANYWAY, IN CASE OF NEW INFORMATION WILL BE MADE AVAILABLE FOR THIS CASE A FOLLOW-UP TO THIS REPORT WILL BE SUBMITTED IN A TIMELY MANNER. THIS INITIAL REPORT IS TO BE CONSIDERED AS FINAL REPORT, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    ON OCTOBER THE 6TH 2023, EL. EN. ELECRTONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US AGENT, EMERGO, IN WHICH THEY FORWARDED US A VOLUNTARY MEDWATCH REPORT CODE (B)(4) RECEIVED FROM THE FDA. IN THE MW REPORT (B)(4) IT IS REPORTED THAT THE PATIENT, FOLLOWING A MONALISA TOUCH (MLT) TREATMENT, EXPERIENCED LOTS OF BLEEDING, BURNS ON THE CERVIX AND ALSO A SCAR ON THE LIVER. MOREOVER PATIENT REPORTS THAT THE DOCTOR WHO PERFORMED THE TREATMENT TO HER FORGOT TO HAVE HER WEAR PROTECTIVE EYE GLASSES. IN THE ABOVE MENTIONED MW REPORT THE PATIENT DID NOT REPORT ANY SPECIFIC DATA ABOUT THE DEVICE (SUCH AS NAME OF THE DEVICE, REF AND SERIAL NUMBER) BUT JUST "MONALISA TOUCH". IN THE MW REPORT THE PATIENT LEFT HER CONTACT INFORMATION (ADDRESS, PHONE NUMBER AND EMAIL). WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER CYNOSURE INC. COMPANY LOCATED IN WESTFORD MA 01886 US, FOR THE INVESTIGATION ON THIS CASE. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. THE INITIAL INVESTIGATION OF THE DEVICE, BY THE US IMPORTER, HELPED IDENTIFY THE ACTUAL MEDICAL DEVICE INVOLVED IN THE EVENT WHICH IS A DEKA SMARTXIDE2 (REF: (B)(4) - S/N: (B)(6)) MANUFACTUER BY EL. EN. ELECRTONIC ENGINEERING SPA AND MARKETED IN THE USA WITH 510(K) NUMBE K133895. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON OCTOBER THE 6TH, 2023 BY EMAIL FROM THE USAGENT AND, ACCORDING TO 21 CFR PART 803 EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION) AND TO SUPPLY A FORMAL RESPONSE TO THE FDA ON THE VOLUNTARY MEDWATCH REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960338 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other