BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTSET GHV GENTAMICIN 40G

    MDR report key: 1530695 · Received November 12, 2009

    Report

    Report Number
    1818910-2009-06389
    Event Type
    Death
    Date Received
    November 12, 2009
    Date of Event
    October 13, 2009
    Report Date
    October 13, 2009
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K033563
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING CLOSING, THE PATIENT CODED AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET GHV GENTAMICIN 40G 87LOD, MBB LOD DEPUY CMW NA 2922908

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death