BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P WITH TOBRAMYCIN

    MDR report key: 617175 · Received June 21, 2005

    Report

    Report Number
    617175
    Event Type
    Death
    Date Received
    June 21, 2005
    Date of Event
    June 5, 2005
    Report Date
    June 5, 2005
    Manufacturer
    STRYKER, HOWMEDIA, OSTEONICS
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A RIGHT HIP ARTHRO PLASTY W/ENDO PROSTHESIS. WHEN CEMENT WAS PLACED, PATIENT BACAME HYPOTENSIVE AND ARRESTED CPR WAS UNSUCCESSFUL. (FAT / CEMENT EMBOLISM SYSPECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P WITH TOBRAMYCIN BONE CEMENT WITH TOBRAMYCIN LOD STRYKER, HOWMEDIA, OSTEONICS * 0473N023

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Death