BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLOWASH

    MDR report key: 375830 · Received February 7, 2002

    Report

    Report Number
    MW1024002
    Event Type
    Malfunction
    Date Received
    February 7, 2002
    Date of Event
    January 24, 2002
    Report Date
    February 7, 2002
    Manufacturer
    COMMUNITY BLOOD CTR AND TISSUE SVS
    Product Code
    LMO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BONE CRUMBLED AND NEEDED TO BE REMOVED FROM THE PT. IT WAS BEING USED AS A CANCELLOUS BONE GRAFT. REPLACED WITH A FROZEN FIBULA STRUT FROM ANOTHER HOSP. PT WAS NOT HARMED. THE PT WAS TO HAVE FUSION AND THE PROBLEM WAS DISCOVERED. THE PHYSICIAN HAS THE REMOVED BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLOWASH BONE GRAFT ALLOGRAFT/CADAVER LMO COMMUNITY BLOOD CTR AND TISSUE SVS NA 01-3287

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR