BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALACOS R WITH GENTAMICIN

    MDR report key: 526946 · Received May 17, 2004

    Report

    Report Number
    9610902-2004-00001
    Event Type
    Death
    Date Received
    May 17, 2004
    Date of Event
    April 29, 2004
    Report Date
    May 17, 2004
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG
    Product Code
    LOD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT UNDERENT SURGERY IN 2004 AND A HIP ENDOPROSTHESIS WAS PUT IN PLACE. PALACOS RE WITH GENTAMICIN CEMENT IMPLANT WAS USED. IMMEDIATELY AFTER THE APPLICATION PT DEVELOPED CIRCULATORY ARREST. RESUSCITATIVE MEASURES WERE TAKEN BUT WITHOUT SUCCESS AND THE PT DIED. CAUSE OF DEATH IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R WITH GENTAMICIN BONE CEMENT LOD HERAEUS KULZER GMBH & CO. KG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death MARCOUMAR, MIXTARD, EPHEDRIN, NORADRENALINE,| KEFZOL, ADRENALIN, ATROPIN, ROCURONIUM BROMIDE,| ETOMIDATE, DORMICUM "ROCHE", FENTANYL.