BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTSET HV 40 G

    MDR report key: 1377924 · Received May 5, 2009

    Report

    Report Number
    1818910-2009-02103
    Event Type
    Death
    Date Received
    May 5, 2009
    Date of Event
    March 12, 2009
    Report Date
    April 6, 2009
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    PMA / PMN Number
    K023012
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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

    DEATH-ANAPHYLACTIC SHOCK 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSET HV 40 G 87LOD LOD DEPUY CMW NA 2641189

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death