BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 21418783 · Received February 20, 2025

    Report

    Report Number
    3001431138-2025-00001
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 1, 2023
    Report Date
    February 14, 2025
    Manufacturer
    EL.EN. ELECTRONIC ENGINEERING S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K133859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE AS MANUFACTURER OF THE DEVICE INVOLVED IN THE EVENT PERFORMED OUR OWN INVESTIGATION BY REQUESTING ALSO THE SUPPORT OF OUR US IMPORTER. THE MW REPORT AND ALL THE AVAILABLE INFORMATION HAS BEEN SHARED WITH THE US IMPORTER, CYNOSURE, IN ORDER TO HAVE THEIR SUPPORT ON THE INVESTIGATION. THE US IMPORTER PERFORMED SEVERAL ATTEMPTS TO TRACE DOWN THE CLINIC WITH THE NAME OF THE PATIENT, BUT WITHOUT ANY SUCCESS. THEY GET BACK TO US INFORMING THAT THEY WERE UNABLE TO PERFORM ANY FURTHER INVESTIGATION DUE TO THE LACK OF ANY USEFUL INFORMATION TO IDENTIFY THE CLINIC, DEVICE OR OTHER USEFUL INFORMATION. BASED ON THE FACT THAT IT WAS IMPOSSIBLE, WITH THE INFORMATION AVAILABLE ON THE MW REPORT, TO IDENTIFY THE DEVICE, THE CLINIC OR ANY OTHER IRRELEVANT INFORMATION IT HAS BEEN IMPOSSIBLE TO PUSH THE INVESTIGATION ANY FURTHER. . THE PRESENT INITIAL REPORT HAS TO BE CONSIDERED AS A FINAL REPORT, AND AN OFFICIAL RESPONSE TO THE MEDWATCH REPORT MW5164072, UNLESS FDA HAS FURTHER QUESTIONS.

    Description of Event or Problem · 0

    IN DATE (B)(6) 2025 OUR US AGENT, (B)(4) INFORMED US OF A COMMUNICATION FROM OUR US AGENT (B)(4) RELATIVE TO A MEDWATCH REPORT RECEIVED FROM THE US FDA. IN THE NARRATIVE PROVIDED IT IS REPORTED THE FOLLOWING: IN SUCH REPORT, CODE MW5164072, THE PATIENT REPORTED THAT THE TREATMENT WAS PERFORMED ON HER DUE TO PAINFUL INTERCOURSE. FOLLOWING THE TREATMENT (SPECIFIED TO HAVE BEEN PERFORMED ON (B)(6) 2023) SHE IS NOW FACING PAIN IN THE VAGINAL OPENING AND LEFT SIDE. IN THE REPORT IS NOT SPECIFIED THE EXACT DEVICE INVOLVED IN THE EVENT. MOREOVER, THE NAME OF THE PHYSICIAN HAS BEEN CENSORED BY THE FDA. THE ONLY INFORMATION ABOUT THE PATIENT IS HER NAME: JENNIFER BROTHERS. THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS NOT BEEN IDENTIFIED IN THE MW REPORT. ANYWAY, THE ONLY TWO DEVICES CAPABLE OF PERFORMING THE MONALISA TOUCH TREATMENT WHICH ARE SMARTXIDE2 AND SMARTXIDE TOUCH MARKETED IN THE US WITH 510(K) K133859. THE PRESENT ADVERSE EVENT HAS BEEN EVALUATED AS A REPORTABLE, IN ACCORDANCE WITH US FDA 21 CFR PART 803, IN ABUNDANCE OF CAUTION (THE PATIENT'S PATHOLOGIES HAS NOT BEEN CONFIRMED WITH FORMAL MEDICAL REPORTS) AND TO SUPPLY FDA WITH A FORMAL RESPONSE TO THE VOLUNTARY MEDWATCH REPORT # MW5164072.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179158 UNKNOWN UNKNOWN GEX EL.EN. ELECTRONIC ENGINEERING S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other