BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 16688064 · Received April 6, 2023

    Report

    Report Number
    3001431138-2023-00002
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    July 20, 2018
    Report Date
    April 6, 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)(4) THAT IS MARKETED IN THE US WITH 510(K) NUMBER: K133895. THE US IMPORTER INTERVIEWED THE PHYSICIAN OF THE CLINIC AND FOUND OUT THAT SHE WAS UNAWARE OF ANY ISSUE WITH THE PATIENT. IN FACT SHE REPORTED TO HAVE PERFORMED THREE TREATMENT ON THE PATIENT AND THAT SHE FELT SATISFIED WITH THE TREATMENT'S RESULTS. IN FACT IT IS REPORTED THAT THE PATIENT HAVE ACTED AS A TESTIMONIAL FOR THE CLINIC. IN THE INFORMATION GATHERED BY THE US IMPORTER IT IS REPORTED THAT THE TREATMENTS WERE PERFORMED ON (B)(6) 2018. MOREOVER THE PHYSICIAN FOUND OUT ONLY AFTER THE FIRST TREATMENT THAT THE PATIENT WAS HSV 1 POSITIVE. ANYWAY IT IS NOT CLEAR IF THIS CONDITION COULD HAVE CONTRIBUTED TO THE PATIENT'S LESIONS. THE EVENT TOOK PLACE AT (B)(6) CLINIC PLACED IN (B)(6), NJ - USA. THE ACTUAL DEVICE INVOLVED IN THE EVENT WAS CHECKED, AS ORDINARY MAINTENANCE, IN JANUARY 2019 AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS (SERVICE REPORT CODE: 00033727). BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THE ACTUAL CAUSE OF THE LESION REPORTED BY THE PATIENT, CONSIDERING ALSO THAT MORE THAN 4 YEARS HAS PASSED SINCE THE TREATMENT'S DATE. THAT SAID, NO CONCLUSION HAS BEEN POSSIBLE TO BE MADE. 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 MARCH THE 15TH 2023, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US AGENT (B)(6), THAT RECEIVED A COMMUNICATION FROM THE FDA CONCERNING AND ADVERSE EVENT HAPPENED TO A PATIENT REPORTED ON THE MEDWATCH SYSTEM. THE PATIENT REPORTED TO THE FDA (MEDWATCH REPORT #MW5115431), ON (B)(6) 2023, AN ADVERSE EVENT HAPPENED TO HER FOLLOWING MONALISA TOUCH TREATMENT, PERFORMED IN 2018, IN WHICH SHE DEVELOPED BURNS AND PERMANENT SCARS. THE PATIENT DID NOT REPORT ANY INFORMATION RELATIVE TO THE DEVICE INVOLVED IN THE EVENT. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER CYNOSURE INC. COMPANY LOCATED IN (B)(6) US, FOR THE INVESTIGATION ON THIS CASE. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. CYNOSURE IMMEDIATELY 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)(4) THAT IS MARKETED IN THE US WITH 510(K) NUMBER: K133895. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON MARCH THE 15TH, 2023 BY EMAIL FROM THE US AGENT AND, ACCORDING TO 21 CFR PART 803 WE EVALUATED THE EVENT REPORTABLE BECAUSE WE HAVE ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION). THE PRESENT MDR REPORT HAS TO BE CONSIDERED, ALSO, AS OUR OFFICIAL RESPONSE TO THE MEDWATCH REPORT CODE MW5115431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799093 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other