BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUSHUNT

    MDR report key: 63933 · Received January 16, 1997

    Report

    Report Number
    1713910-1997-00001
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    October 2, 1996
    Report Date
    January 16, 1997
    Manufacturer
    RESEARCH MEDICAL, INC.
    Product Code
    DQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF A CAROTID SHUNT THE BALLOON CAME APART. THE SHUNT WAS REPLACED WITH NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUSHUNT CAROTID SHUNT DQR RESEARCH MEDICAL, INC. NA 039504

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other