BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLIAM HARVEY

    MDR report key: 226334 · Received May 28, 1999

    Report

    Report Number
    MW1016469
    Event Type
    Injury
    Date Received
    May 28, 1999
    Date of Event
    June 2, 1998
    Report Date
    May 25, 1999
    Manufacturer
    C.R. BARD, INC.
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FORM MFR. ON 7/09/1999: IT WAS DETERMINED THAT THIS INCIDENT WAS PREVIOUSLY FILED UNDER MEDWATCH NUMBER 1217435-1998-00199 FOR ITEM NUMBER 007314 (CORRECT BARD ITEM NUMBER). NO DEVICE WAS RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS ITEM INDICATED THAT THERE WERE NO MANUFACTURING ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILLIAM HARVEY AORTIC CANNULA DWF C.R. BARD, INC. GA335 24F SPECIAL *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention