BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLEX P WITH TOBRAMYCIN

    MDR report key: 604168 · Received May 5, 2005

    Report

    Report Number
    604168
    Event Type
    Other
    Date Received
    May 5, 2005
    Date of Event
    October 29, 2004
    Report Date
    May 5, 2005
    Manufacturer
    HOWMEDICA INTERNATIONAL S. DE R.L.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED CARDIOPULMONARY ARREST FOLLOWING A 3 LEVEL KYPHOPLASTY WITH INJECTION OF BONE CEMENT. WHILE STILL IN OR AT 1145 02 SATS DECREASED FROM 100 TO 55, END TIDAL C02 DECREASED TO 18 WHICH WAS DOCUMENTED AS CONSISTENT WITH PULMONARY EMBOLISM. A FULL CODE WAS CALLED. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL.

    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 89 YR Other