BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACIST

    MDR report key: 558583 · Received December 6, 2004

    Report

    Report Number
    2134243-2004-00011
    Event Type
    Other
    Date Received
    December 6, 2004
    Report Date
    December 3, 2004
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AIR WAS INJECTED INTO THE PATIENT DURING AN ANGIOGRAPHIC PROCEDURE. A HEALTH CARE PROFESSIONAL AT THE USER FACILITY REPORTED THAT THERE WERE NO MAJOR COMPLICATIONS WITH THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY BUT AS OF THE DATE OF THIS REPORT THERE NO MAJOR COMPLICATIONS WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS, INC. CMS2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other