BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLEX P WITH TOBRAMYCIN

    MDR report key: 604173 · Received May 5, 2005

    Report

    Report Number
    604173
    Event Type
    Other
    Date Received
    May 5, 2005
    Date of Event
    December 3, 2004
    Report Date
    May 5, 2005
    Manufacturer
    HOWMEDICA INTERNATIONAL S. DE R.L.
    Product Code
    LOD
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT KYPHOPLASTY, 3 LEVELS WITH THE INJECTION OF BONE CEMENT. SHORTLY AFTER THE PROCEDURE ENDED AT 922, THEIR O2 SATS DROPPED FROM 98 TO 88, BP FROM 102/56 TO 102/40, PULSE DECREASED TO 40. PT WAS INTUBATED AFTER A POOR RESPONSE TO MEDICATIONS AND TRANSFERRED TO ICU. THE PT EXPIRED A1030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P WITH TOBRAMYCIN BONE CEMENT LOD HOWMEDICA INTERNATIONAL S. DE R.L. * MDL010

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other