BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYSONIS

    MDR report key: 511416 · Received February 5, 2004

    Report

    Report Number
    MW1031099
    Event Type
    Malfunction
    Date Received
    February 5, 2004
    Date of Event
    February 3, 2004
    Report Date
    February 4, 2004
    Manufacturer
    BYRON MEDICAL, INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIPECTOMY AND DURING ABDOMINOPLASTY WITH A UAL DEVICE (ULTRASOUND ASSISTED LIPECTOMY) THE SURGEON NOTED A BLISTERING EFFECT AROUND THE SIDE PORT (SUCTION PORTS). A TEFLON-COATED CATHETER GUARD WAS ON THE UAL. IT APPEARED TO HAVE CAUSED AN ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYSONIS UAL ULTRASOUND PROBE SLEEVE ITX BYRON MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other