BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 2992836 · Received February 27, 2013

    Report

    Report Number
    1820334-2013-00090
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DISTAL END OF SHEATH DETACHED INSIDE THE PT. THE DEVICE WAS SNARED OUT VIA THE LEFT SIDE OF THE BODY ONE TO TWO UNITS OF BLOOD WERE GIVEN TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84135 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA 3808286

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention