BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 1972475 · Received January 20, 2011

    Report

    Report Number
    1820334-2011-00047
    Event Type
    Death
    Date Received
    January 20, 2011
    Report Date
    December 22, 2010
    Manufacturer
    COOK, INC.
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED TO COOK BY AN AREA REP THAT ON (B)(6) 2010, THE REP WAS TO ATTEND A DOLPHIN BALLOON ASSISTED TRACHEOSTOMY (BAT) CASE IN THE OPERATING ROOM AT (B)(6) MEDICAL CENTER. UPON ARRIVAL, THE ATTENDING PHYSICIAN INFORMED THE REP THAT IN THE LAST CASE WHEN THE FACILITY USED A COOK TRACHEOSTOMY DEVICE, THE PT DIED ON THE TABLE. IT WAS EXPLAINED THAT THE PHYSICIAN DID NOT FEEL IT WAS THE PRODUCT'S DOING, BUT A RESULT OF THE PROCEDURE. NO INFORMATION WAS PROVIDED REGARDING PT (SEX, WEIGHT, AGE, ETC). THE PHYSICIAN WAS NOT CERTAIN AS TO WHICH TRACHEOSTOMY PRODUCT OF COOK'S WAS USED. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2010 THAT THE EXPIRED PT WAS NOT THE REPORTING PHYSICIAN'S PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET KCG DILATOR, TRACHEAL KCG COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death