BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORPORATION

    MDR report key: 539531 · Received May 5, 2004

    Report

    Report Number
    1317056-2004-00012
    Event Type
    Malfunction
    Date Received
    May 5, 2004
    Date of Event
    April 7, 2004
    Report Date
    April 7, 2004
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER HOSPITAL RECEIVED THREE UNITS OF CUSTOM CONVENIENCE KIT ON WHICH ONE END OF THE KIT POUCH WAS NOT SEALED. THE KITS WERE NOT USED. TWO KITS WERE THROWN AWAY, ONE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORPORATION CUSTOM ANGIOGRAPHIC CONVENIENCE KIT DTL BOSTON SCIENTIFIC/NAMIC NA 941004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN