BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 10918787 · Received November 30, 2020

    Report

    Report Number
    3001431138-2020-00004
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    June 1, 2016
    Report Date
    November 30, 2020
    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 · 1

    WE, THE MANUFACTURE OF THE DEVICE, AND OUR US IMPORTER PERFORMED OUR INVESTIGATION BY CONTACTING THE PATIENT IN ORDER TO GATHER MORE DETAILED INFORMATION ON THE EVENT. THE PATIENT INFORMED OUR US IMPORTER, CYNOSURE, OF THE PLACE WHERE THE TREATMENT HAS BEEN PERFORMED IN 2016, WHICH IS (B)(6). THE PHYSICIAN WHO PERFORMED THE TREATMENT WAS (B)(6). THE INFORMATION RELATED TO THE CLINIC WHERE THE PATIENT WAS TREATED ALLOWED US TO IDENTIFY THE DEVICE THERE INSTALLED, WHICH IS A DEKA SMARTXIDE2 ((B)(4)). THE PATIENT REPORTED TO OUR US IMPORTER THAT SHE DID NOT RETURN TO (B)(6) FOR ASSESSMENT. SHE DID NOT PROVIDE ADDITIONAL INFORMATION REGARDING HER SYMPTOMS OTHER THAN (B)(6) OFFERED ADDITIONAL MEDICAL GUIDANCE WHICH CHE REFUSED DUE TO HAVING TO PAY. THE PHYSICIAN HAS BEEN CONTACTED SEVERAL TIMES BY THE US IMPORTER, BY PHONE AND EMAILS, BUT HE DID NOT RETURN EITHER. NO OTHER DETAILS REGARDING THE TREATMENT HAS BEEN DISCLOSED. ANYWAY THE DEVICE HAS BEEN EVALUATED IN 2017, AS A ROUTINARY MAINTENANCE, BY US IMPORTER AUTHORIZED TECHNICAL SERVICE PERSONNEL AND FOUND TO BE WORKING PROPERLY WITHIN SPECIFICATIONS (SERVICE REPORT # (B)(4) PERFORMED IN DATE 10/06/2017). BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S SYMPTOMS. ANYWAY, DUE TO THE FACT THAT THE DEVICE HAS BEEN FOUND TO BE WORKING PROPERLY, WE DO NOT SUSPECT THAT A DESIGN ISSUE COULD HAVE CAUSED THE EVENT. THE INVESTIGATION CARRIED OUT BASED ONLY ON THE LIMITED INFORMATION MADE US IMPOSSIBLE TO DETERMINE THE EXACT CONCLUSION FOR THIS EVENT. NO REMEDIAL ACTION REQUIRED - DEVICE WORKING WITHIN SPECIFICATIONS. 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 · 1

    ON NOVEMBER THE 6TH, 2020, EL.EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY US AGENT EMERGO, THAT RECEIVED A COMMUNICATION FROM THE FDA, CONCERNING AN ADVERSE EVENT HAPPENED TO A PATIENT RECORDED ON THE MEDWATCH SYSTEM WITH REPORT # MW5097028. THE PATIENT REPORTED TO THE FDA (MEDWATCH REPORT #MW5097028), THAT ON (B)(6) 2020, AN ADVERSE EVENT HAPPENED TO HER, FOLLOWING 6 MONALISA TOUCH TREATMENT PERFORMED IN DATE (B)(6) 2016. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT WAS NOT IDENTIFIED BY THE PATIENT IN THE MEDWATCH REPORT: MW5097028. ANYWAY THE PATIENT SUPPLIED HER GENERALITIES AND CONTACT INFORMATION ON THE MW5097028 REPORT. THE PATIENT REPORTED THAT SHE COULD ALLEVIATE HER ISSUE OF VAGINAL ATROPHY, WHICH WERE CAUSED BY TAKING FEMERA FOR ESTRONGEN FED BREAST CANCER WITH THE MONLISA TREATMENT. THE PATIENT SAW THE DOCTOR FOR THE TREATMENT AND AFTER 6 TREATMENTS HER SYMPTOMS OF VAGINAL DRYNESS AND PAIN WERE NO BETTER. SHE IS NOW COMPLAINING TO HAVE SCAR TISSUE FROM THE MONALISA TREATMENT WHICH MADE HER VAGINAL DRYNESS AND SHRINKAGE WORSE. THE PATIENT REPORTED THE FOLLOWING AS CONCOMITANT MEDICAL: FEMERA, BUPROPION, MIRAPEX, VITAMIN D. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER CYNOSURE INC. COMPANY LOCATED IN (B)(4), FOR THE INVESTIGATION ON THIS CASE. CYNOSURE WAS INFORMED BY THE MANUFACTURER IN DATE NOVEMBER THE 6TH, 2020, AND IMMEDIATELY STARTED ITS INVESTIGATION. CYNOSURE INC. ALSO REPRESENTS US DISTRIBUTOR AND SERVICE CENTER FOR EL.EN. ELECTRONIC ENGINEERING SPA MEDICAL DEVICES. CYNOSURE INC. EVALUATED THE EVENT AS REPORTABLE BECAUSE THE SCARRING CAN BE ASSUMED AS A SERIOUS INJURY, AND SUBMITTED ITS OWN MDR REPORT #MDR-1222993-2020-00023 IN DATE NOVEMBER THE 25TH, 2020. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON NOVEMBER THE 6TH, 2020 BY EMAIL FROM THE US AGENT AND, ACCORDING TO 21 CFR PART 803.50(2), SUBMITTED TO FDA AN OWN MDR REPORT IN ORDER TO SUBMIT ADDITIONAL INFORMATION FORM THE REPORT SUBMITTED BY THE US IMPORTER. MOREOVER, WE EVALUATED THE EVENT REPORTABLE BECAUSE THE PATIENT RECEIVED MEDICAL ATTENTION FOLLOWING THE LASER PROCEDURE. THE PRESENT REPORT HAS TO BE CONSIDERED ALSO AS RESPONSE TO THE MEDWATCH REPORT #MW5097028 RECEIVED BY THE MANUFACTURER, THROUGH OUR US AGENT, IN DATE NOVEMBER THE 6TH, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382400 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL.EN. ELECTRONIC ENGINEERING S.P.A. M103P1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other