BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 18092923 · Received November 8, 2023

    Report

    Report Number
    1222993-2023-00014
    Event Type
    Injury
    Date Received
    November 8, 2023
    Date of Event
    August 28, 2017
    Report Date
    November 8, 2023
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING S.P.A
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    CYNOSURE RECEIVED MEDWATCH REPORT # MW5146036 ON (B)(6) 2023 WITH PATIENT REPORTED EXPERIENCING BLEEDING, BURNING ON THE CERVIX, AND A SCAR ON THE LIVER FOLLOWING A MONALISA TOUCH TREATMENT USING SMARTXIDE2. PATIENT ONLY COMPLAINED OF SYMPTOMS AFTER FOURTH MONALISA TOUCH TREATMENT. TREATMENT DATES WERE: (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, AND (B)(6) 2017. CYNOSURE CLINICAL TEAM REACHED OUT TO SITE WHO COMMUNICATED THAT PATIENT NEVER REPORTED THE SYMPTOMS TO THEM EVEN AFTER MULTIPLE FOLLOW UP APPOINTMENTS FROM LAST TREATMENT. SITE ALSO MENTIONED THAT PATIENT IS ON DEPRO PROVERA CONTRACEPTIVE INJECTION PRIOR TO TREATMENTS. A SERVICE EVALUATION HAS BEEN SCHEDULED AND A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL RELEVANT DATA BECOMES AVAILABLE. THERE IS NOT ENOUGH INFORMATION AT THIS TIME TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE EVENT. CYNOSURE IS REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION AND BASED ON THE INFORMATION IN THE MEDWATCH REPORT STATING THE PATIENT SUSTAINED A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537268 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL. EN. ELECTRONIC ENGINEERING S.P.A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other