BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK INC

    MDR report key: 649286 · Received December 1, 2005

    Report

    Report Number
    649286
    Event Type
    Malfunction
    Date Received
    December 1, 2005
    Date of Event
    September 6, 2005
    Report Date
    November 1, 2005
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PHYSICIAN WAS DOING INSERTION OF PERMACATH PROCEDURE, TIP OF GUIDE WIRE BROKE OFF. PHYSICIAN DECIDED TO LEAVE TIP IN PT, AS IT WAS SAFER THAN RETRIEVING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC MICROPUNCTURE DYB COOK, INC. MPIS-S01 1534118

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other