BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASER SYSTEM

    MDR report key: 2923337 · Received October 12, 2006

    Report

    Report Number
    1725012-2006-00001
    Event Type
    Other
    Date Received
    October 12, 2006
    Date of Event
    September 29, 2006
    Report Date
    September 21, 2006
    Manufacturer
    SOUND SURGICAL TECHNOLOGIES LLC.
    Product Code
    LFL
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION KNOWN TO SOUND SURGICAL AT THIS TIME, WHICH CONSISTS OF A FIRST-HAND ACCOUNT BY THE SURGEON, NO FAILURE OR MALFUNCTION OF THE VASER SYSTEM WAS ALLEGED BY THE USER. THE ROOT CAUSE REASONABLY SUGGESTS THE AREA WHERE THE INJURY OCCURRED WAS EITHER UNDER-INFUSED OR NOT INFUSED.

    Description of Event or Problem · 1

    SURGEON CONTACTED SOUND SURGICAL TO DISCUSS A CASE WHEREIN A PATIENT REPORTED PAIN AND SWELLING IN ONE MEDIAL THIGH AREA. FIVE OF SIX AREAS TREATED HAD EXPECTED RESULTS AND HEALED NORMALLY. BASED ON A DISCUSSION BETWEEN SOUND SURGICAL AND THE SURGEON, SOUND SURGICAL BELIEVES THE VASER PERFORMED NORMALLY, WITHOUT FAILURE OR MALFUNCTION. THE BASIS OF THIS INJURY APPEARS TO BE UNDER-INFUSION OR NO INFUSION OF THE MEDIAL THIGH AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASER SYSTEM ULTRASONIC AMPLIFIER LFL SOUND SURGICAL TECHNOLOGIES LLC. VASER-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other