BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEKA SMARTXIDE2

    MDR report key: 19273686 · Received May 8, 2024

    Report

    Report Number
    1222993-2024-00024
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    September 12, 2023
    Report Date
    May 8, 2024
    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 # MW5153316 ON 16 APR 2024 WITH PATIENT REPORTED EXPERIENCING BLEEDING AND PAIN FOLLOWING MONALISA TOUCH TREATMENTS USING SMARTXIDE2. PATIENT ALSO REPORTED EXPERIENCING BURN WITH URINATION AND PAIN DURING INTERCOURSE. CYNOSURE'S CLINICAL TEAM INVESTIGATED THE EVENT AND DETERMINED IT TO BE INCONCLUSIVE. TREATMENT PARAMETERS WERE WITHIN RECOMMENDED GUIDELINES. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. 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 PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99045 DEKA SMARTXIDE2 DEKA SMARTXIDE2 GEX EL. EN. ELECTRONIC ENGINEERING S.P.A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other