BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK MEDICAL

    MDR report key: 1182463 · Received September 18, 2008

    Report

    Report Number
    1182463
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    April 29, 2008
    Report Date
    September 18, 2008
    Manufacturer
    COOK , INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EMERGENT SURGERY FOR ACUTE EMBOLUS. DEVELOPED A HEMATOMA IN RIGHT GROIN AT SITE OF SHEATH. CUT-DOWN DONE AT RIGHT GROIN AREA, WHERE A HEMATOMA WAS REMOVED, AND SHEATH FOUND TO HAVE A 3MM HOLE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MEDICAL SHEATH DYB COOK , INC. RCF N 5.0 18 MPIS *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR