BEUDAMED
    FDA Adverse Event Death Summary report: N

    CMW 1 BONE 1 40 G

    MDR report key: 493652 · Received November 5, 2003

    Report

    Report Number
    1818910-2003-00724
    Event Type
    Death
    Date Received
    November 5, 2003
    Date of Event
    October 6, 2003
    Report Date
    October 6, 2003
    Manufacturer
    DEPUY CMW
    Product Code
    LOD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "PT HAD A GA AND FASCIA ILIAC BLOCK FOR A RIGHT HEMIARTHROPLASTY. PT WAS DOING WELL UNTIL THE MOMENT WHEN THE CEMENT WAS INSERTED INTO THE FEMUR. THE PTS BLOOD PRESSURE COULD NOT BE RECORDED, PULSE RATE DROPPED TO 29 BPM AND THE MONITOR SPO2 NOT RECORDABLE. ATROPINE AND ADRENALINE GIVEN. PT VENTILATED WITH 100% O2 AND ASSISTANCE SOUGHT FROM ANOTHER DR. CPR COMMENCED AND AFTER 15 MINUTES THE SITUATION IMPROVED AND THE PT WAS TRANSFERRED. THE PT REMAINS CRITICAL. THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMW 1 BONE 1 40 G CEMENT LOD DEPUY CMW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death