BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASER LIPO SYSTEM

    MDR report key: 1609395 · Received February 12, 2010

    Report

    Report Number
    MW5014764
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 12, 2010
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES
    Product Code
    MUU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A SUPERFICIAL BURN TO THE RIGHT BUTTOCKS -2X3CM- AND RIGHT BUTTOCKS PORT SITE FROM THE VASER LIPOSUCTION CANNULA. AREA WAS WELL PROTECTED WITH WET TOWELS AND WET LAPS. DEVICE SUSPECTED TO BE AT FAULT. AREA DRESSED WITH SILVER SULFADIAZINE AND ADAPTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASER LIPO SYSTEM NONE MUU SOUND SURGICAL TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability