BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 14945774 · Received July 7, 2022

    Report

    Report Number
    3001431138-2022-00007
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    February 3, 2022
    Report Date
    July 7, 2022
    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 WERE UNABLE TO INVESTIGATE ANY FURTHER DUE TO THE FACT THAT THE REPORT MW5109813 DID NOT HAVE ANY CONTACT INFORMATION OF THE PATIENT, NO INFORMATION ABOUT THE CLINIC WHERE THE EVENT TOOK PLACE NOR ANY INFORMATION ABOUT THE ACTUAL DEVICE INVOLVED IN THE EVENT. THAT SAID IT WAS IMPOSSIBLE TO GATHER ANY MORE INFORMATION AND TO FURTHER INVESTIGATE ON THIS CASE. BASED ON THAT AND THE FACT THAT ANY FURTHER INVESTIGATION RESULTED IMPOSSIBLE. 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 (B)(6) 2022, EL. EN. ELECTRONIC ENGINEERING SPA BECAME AWARE OF AN ADVERSE EVENT, REPORTED BY THE US AGENT EMERGO, 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 #MW5109813), ON (B)(6) 2022, AN ADVERSE EVENT HAPPENED TO HER FOLLOWING MONALISA TOUCH TREATMENT PERFORMED ON (B)(6) 2022. THE ACTUAL MEDICAL DEVICE INVOLVED IN THIS EVENT WAS NOT IDENTIFIED BY THE PATIENT IN THE MEDWATCH REPORT. MOREOVER NO INFORMATION ABOUT THE PATIENT WERE AVAILABLE ON THE MW REPORT #MW5109813 SUCH AS NAME, ADDRESS, PHONE NUMBER, EMAIL NOR ANY INFORMATION ABOUT THE CLINIC WHERE THE EVENT TOOK PLACE. IN THE MEDWATCH REPORT MW5109813 THE PATIENT REPORTED TO HAVE UNDERWENT TWO OF THE THREE SCHEDULED MLT TREATMENT IN ORDER TO ALLEVIATE HER PAIN DURING INTERCOURSE CAUSED BY MENOPAUSE. THE PATIENT REPORTED THAT FOLLOWING THE TWO TREATMENTS HER PAIN DURING INTERCOURSE HAS GONE WORSE. SHE REPORTED HER PAIN TO THE PHYSICIAN WHO PERFORMED THE TWO TREATMENT. THAN THE PHYSICIAN DECIDED TO NOT PERFORM THE THIRD TREATMENT IN ORDER TO AVOID TO WORSEN THE SITUATION. THE PATIENT ALSO REPORT TO HAVE NOT BEING INFORMED OF ANY POSSIBLE SIDE EFFECTS OR POTENTIAL HARM FOLLOWING THE TREATMENT. THE PATIENT DID NOT REPORT ANY INFORMATION RELATIVE TO THE DEVICE INVOLVED IN THE EVENT. ANYWAY THE ONLY TWO DEVICES THAT CAN PERFORM THE MONALISA TOUCH TREATMENT ARE THE SMARTXIDE2 AND SMARTXIDE TOUCH AND BOTH ARE MANUFACTURED BY EL.EN. ELECTRONIC ENGINEERING SPA AND MARKETED IN THE UNITED STATES WITH 510(K) NUMBER K133895. WE, THE MANUFACTURER OF THE DEVICE, REQUESTED THE COOPERATION OF OUR US IMPORTER (B)(4) COMPANY LOCATED IN (B)(4) 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 INC. EVALUATED THE EVENT AS REPORTABLE BECAUSE THEY ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION) AND SUBMITTED ITS OWN MDR REPORT (B)(4) AS IMPORTER OF THE DEVICE. WE, THE MANUFACTURER OF DEVICE, BECAME AWARE OF THE EVENT ON JUNE THE 9TH, 2022 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 WE HAVE ASSUMED THE LESIONS TO BE A SERIOUS INJURY (ON THE SIDE OF CAUTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256627 UNKNOWN UNKNOWN GEX EL.EN. ELECTRONIC ENGINEERING S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other