BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONE LS PLUNGER

    MDR report key: 10697849 · Received October 16, 2020

    Report

    Report Number
    MW5097299
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    May 6, 2020
    Report Date
    October 14, 2020
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HAWKONE LS PLUNGER QUIT WORKING. UNDER FURTHER EXAMINATION, METAL PIECE SHOWING OFF TIP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152993 HAWKONE LS PLUNGER INTRALUMINAL ARTERY STRIPPER DWX MEDTRONIC VASCULAR 0009763205

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR