BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDRAD ANGIOGRAPHIC INJECTOR

    MDR report key: 305516 · Received November 20, 2000

    Report

    Report Number
    2520313-2000-00015
    Event Type
    Other
    Date Received
    November 20, 2000
    Date of Event
    September 29, 2000
    Report Date
    November 15, 2000
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP CALLED REQUESTING CHECKOUT OF THE ANGIOGRAPHIC INJECTOR. DURING PROCEDURES IN 2000, THEY HAD TWO PTS SUFFER STROKES. IN 2000, ANOTHER PT SUFFERED A STROKE IMMEDIATELY FOLLOWING THE PROCEDURE. ALL PTS ARE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDRAD ANGIOGRAPHIC INJECTOR ANGIOGRAPHIC INJECTOR DXT MEDRAD, INC. MKV+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| R