BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHWICK CAROTID SHUNT

    MDR report key: 8428351 · Received March 15, 2019

    Report

    Report Number
    MW5084960
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    June 9, 2018
    Report Date
    March 14, 2019
    Manufacturer
    IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC.
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    LOT # CSO13118-02 BALLOON COULD NOT BE INFLATED. LOT # CS0 80116-01 ALSO DIFFICULT TO INFLATE ONE OF THE BALLOONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216679 SMITHWICK CAROTID SHUNT CLAMP VASCULAR DXC IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC. CS080116-01
    216680 SMITHWICK CAROTID SHUNT CLAMP VASCULAR DXC IMPLANTABLE DEVICES / MCPHERSON ENTERPRISES, INC. CS013118-01

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR