BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYSONIX 3000 UAL SYSTEM

    MDR report key: 2302207 · Received October 14, 2011

    Report

    Report Number
    MW5022673
    Event Type
    Injury
    Date Received
    October 14, 2011
    Date of Event
    October 3, 2011
    Report Date
    October 14, 2011
    Manufacturer
    BYRON MEDICAL
    Product Code
    MUU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE LYSONIX 3000 ULTRASOUND ASSISTED LIPOPLASTY SYSTEM, THERE WAS A SUPERFICIAL BURN OF THE SUPRAUMBILICAL SKIN STATUS POST ULTRASOUND AND PULSED ULTRASONIC LIPOSUCTION. THERE WAS SOME BLISTERING OF THE SKIN, 1 CM ABOVE THE STAB WOUND INCISION. THERE WAS NO EVIDENCE OF DISRUPTION OF THE WHITE INSULATED SHEATH OF THE USL. (B)(6). DATES OF USE: (B)(6) 2004 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYSONIX 3000 UAL SYSTEM UAL MUU BYRON MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other