BEUDAMED
    FDA Adverse Event Death Summary report: N

    0306563000

    MDR report key: 492820 · Received October 29, 2003

    Report

    Report Number
    2648666-2003-20005
    Event Type
    Death
    Date Received
    October 29, 2003
    Date of Event
    September 14, 2003
    Report Date
    October 28, 2003
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    JDZ
    Removal / Correction Number
    Z-921-3
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT DEATH WAS REPORTED WITH ALLEGATION THAT IT MAY HAVE BEEN RELATED TO THE ACM PRODUCT RECALL. THE DEATH CERTIFICATE ALLEGES THAT THE CAUSE OF DEATH IS FROM SEPSIS, MSRA-INFECTION, FAILED HIP PROSTHESIS INFECTION. AN ORIGINAL REPORT FROM THE HOSP IN 6/2003, WITH NO PT NAME PROVIDED, INDICATED THE RESULTS FROM A CULTURE AS BEING "ENTERBACTER CLOACAE." IT WAS REPORTED BY HOSP STAFF IN 7/2003 THAT THE DOCTOR FELT, "THE PT IS BELIEVED TO HAVE AN INFECTION FROM LAYING FOR A LONG PERIOD OF TIME AT ANOTHER FACILITY." THE DOCTOR FELT THIS COMPLAINT WAS NOT RELATED TO THE STRYKER RECALLED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 0306563000 ADVANCED CEMENT MIXING BOWL AN JDZ STRYKER INSTRUMENTS 0306-563-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death