BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK-FLO SHEATH INTRODUCER SET

    MDR report key: 1070936 · Received July 3, 2008

    Report

    Report Number
    1820334-2008-00345
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DEVICE WAS USED WITH ANOTHER MANUFACTURER'S BALLOON AND UPON REMOVING THE SHEATH, IT WAS NOTED THAT THE SHEATH UNRAVELED. THIS EVENT DID NOT AFFECT THE PATIENT. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK-FLO SHEATH INTRODUCER SET DYB INTRODUCER, CATHETER DYB COOK, INC. 2078249

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR