BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR BALKIN GUIDING SHEATH

    MDR report key: 2573378 · Received May 4, 2012

    Report

    Report Number
    1820334-2012-00280
    Event Type
    Malfunction
    Date Received
    May 4, 2012
    Date of Event
    March 9, 2010
    Report Date
    March 2, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION OF DATES REQUESTED ON 05/03/2012. (B)(4). EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A COMPLAINT WAS REPORTED VIA LETTER TO THE DISTRIBUTOR. INTRODUCER WAS BROUGHT INTO THE LEFT INGUINAL SIDE AND HAPPENED TO BE TORN OFF AT THE POINT OF PUNCTURE. THE PRODUCT WAS REMOVED AND DISPOSED. NO INFO WAS PROVIDED REGARDING PT OR OUTCOME OF PT. THE MFR (COOK INCORPORATED) WAS NEVER OFFICIALLY NOTIFIED OF THIS COMPLAINT FROM DISTRIBUTOR CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR BALKIN GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention