BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMERAL HEAD/TISSUE

    MDR report key: 436636 · Received January 9, 2003

    Report

    Report Number
    436636
    Event Type
    Other
    Date Received
    January 9, 2003
    Date of Event
    April 1, 2002
    Report Date
    May 23, 2002
    Manufacturer
    AMERICAN RED CROSS
    Product Code
    LMO
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HUMERAL HEAD (TISSUE) RETREIVED FROM FREEZER FOR IMPLANTATION; DURING COURSE OF IMPLANTATION, STAFF NOTIFIED SURGEON THAT PACKAGING EXPIRATION DATE WAS 12/16/2001. THIS SURGERY WAS IN 2002. TISSUE SUPPLIED BY FEDERAL AGENCY; THE REPORTER HAS BEEN IN CONTACT WITH TECH REP WITH FEDERAL AGENCY WHO SAYS THAT EXPIRATION IS REFLECTIVE OF PACKAGING INTEGRITY; ATTEMPTING TO ACQUIRE INFO FROM THE PROCESSING AGENCY FOR FEDERAL AGENCY- INFO STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL HEAD/TISSUE HUMAN TISSUE LMO AMERICAN RED CROSS NA 920140

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other