BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 2850076 · Received October 15, 2012

    Report

    Report Number
    2850076
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 15, 2012
    Manufacturer
    COOK MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    COOK MEDICAL 6F SHEATH BROKE FOLLOWING COMPLETION OF CASE WHILE BEING REMOVED FROM PATIENT'S LEFT ARM, LEAVING DISTAL PART IN THE PATIENT. DR THEN CONVERTED TO AN OPEN PROCEDURE TO REMOVE BROKEN OFF PIECE AND TO REVISE PATIENT DIALYSIS ACCESS USING PIECE OF GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, INTRODUCER DYB COOK MEDICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R