BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORADO

    MDR report key: 1920873 · Received December 8, 2010

    Report

    Report Number
    MW5018523
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BARD
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER PACKAGE INDICATES SIZE: 6MM X 4CM. STERILE PACKAGING ALSO INDICATED AS 6MM X 4CM CATHETER. CATHETER INSIDE WAS STAMPED 8MM X 4CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORADO PTA DILATATION CATHETER LIT BARD 93HUC102

    Patients

    Seq Age Sex Outcome Treatment
    1