BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P WITH TOBRAMYCIN

    MDR report key: 1639101 · Received March 19, 2010

    Report

    Report Number
    MW5015238
    Event Type
    Death
    Date Received
    March 19, 2010
    Date of Event
    November 16, 2009
    Report Date
    March 19, 2010
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED A CARDIAC ARREST AFTER THE INJECTION OF THE BONE CEMENT DURING PLACEMENT OF HER PROSTHESIS RIGHT TOTAL HIP REPLACEMENT REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P WITH TOBRAMYCIN ANTIBIOTIC BONE CEMENT LOD HOWMEDICA OSTEONICS MIQ053

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death