BEUDAMED
    FDA Adverse Event Other Summary report: N

    VEINLITE

    MDR report key: 2500944 · Received March 16, 2012

    Report

    Report Number
    MW5024703
    Event Type
    Other
    Date Received
    March 16, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 16, 2012
    Manufacturer
    TRANSLITE LLC
    Product Code
    KYT
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON ASSESSMENT OF THE PT, RN NOTED SEVERAL INCOMPLETE RED CIRCULAR MARKS OVER A PREVIOUS IV ATTEMPT SITES. TWO ON HIS RIGHT INNER LOWER FOREARM. ONE ON HIS INNER LOWER RIGHT FOREARM AND TWO ON HIS LOWER RIGHT INNER ANKLE. THE SHAPE IS CONSISTENT WITH THE VEINLITE USED DURING THE IV ATTEMPTS. NO TREATMENTS WERE NEEDED. AREAS WERE LEFT OPEN TO AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VEINLITE VEIN LOCATOR KYT TRANSLITE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Other