BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR CHECK-FLO

    MDR report key: 1103803 · Received July 31, 2008

    Report

    Report Number
    1103803
    Event Type
    Malfunction
    Date Received
    July 31, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 31, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE SHEATH BROKE WHEN THE PHYSICIAN WAS PASSING A WIRE THROUGH IT, AND BECAME LODGED IN THE PATIENT'S BODY. AN OPEN SURGERY OF THE RIGHT GROIN WAS DONE TO RETRIEVE THE DISLODGED SHEATH. NO PIECES OF THE SHEATH WERE LEFT IN THE PATIENT, WHICH WAS VERIFIED VIA X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR CHECK-FLO INTRODUCER, RADIAL ARTERY DYB COOK, INC. G13009 2103794

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR