BEUDAMED
    FDA Adverse Event Other Summary report: N

    PSI-TEC III ASPIRATION PLATFORM 110V

    MDR report key: 1437087 · Received August 7, 2009

    Report

    Report Number
    1645337-2009-00041
    Event Type
    Other
    Date Received
    August 7, 2009
    Date of Event
    June 26, 2009
    Report Date
    August 6, 2009
    Manufacturer
    BYRON MEDICAL
    Product Code
    GDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER A MEDWATCH FROM THE HOSPITAL, THE PT WAS UNDERGOING CORRECTION OF GYNECOMASTIA WITH BILATERAL MASTECTOMY AND ULTRASONIC LIPOSUCTION WHEN A SMALL BURN WAS NOTED. THE AREA WAS EXCISED AND SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI-TEC III ASPIRATION PLATFORM 110V ASPIRATION PLATFORM GDM BYRON MEDICAL 02

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other