BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 240V

    MDR report key: 16386285 · Received February 15, 2023

    Report

    Report Number
    MW5114975
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 6, 2023
    Manufacturer
    VENUS CONCEPT, INC.
    Product Code
    PBX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEGACY: A 39 Y/O PT WENT THROUGH A COUPLE OF VENUS LEGACY TREATMENT ON HER ABDOMEN FOR HAVING EXCESSIVE LOOSE SKIN AND SCRATCH MARKS. A HEMATOMA WAS REPORTED DUE TO THE TREATMENT. THE INTERVAL OF HER TREATMENT WAS ONCE A WEEK FOR 20-MINUTES FOR THE ENTIRE ABDOMEN. THE TEMPERATURE REACHED 41 DEGREES C AS PER THE PROTOCOL AND PER PATIENT HEAT TOLERANCE USING THE OCTIPOLAR. TWO DAYS AFTER HER LAST TREATMENT, SHE FELT A BIG LUMP ON HER LEFT SIDE OF THE ABDOMEN AND MADE HER FEEL IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358622 LEGACY 240V MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX VENUS CONCEPT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention