BEUDAMED
    FDA Adverse Event Death Summary report: N

    TISSUE ALLOGRAFT

    MDR report key: 29161 · Received December 28, 1995

    Report

    Report Number
    MW1008027
    Event Type
    Death
    Date Received
    December 28, 1995
    Date of Event
    December 1, 1992
    Report Date
    December 28, 1995
    Manufacturer
    AMERICAN RED CROSS
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER RPTR, APPARENTLY, THE DONOR BLOOD AND TRANSPORT SOLUTION TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA, BUT AFTER EXPOSURE TO THE ANTIBIOTIC COCKTAIL, THE COCKTAIL AND CO-PROCESSED TISSUE CULTURED NEGATIVE, SO THE PROCESSOR FELT THAT THE TISSUE WAS STERILE AND RELEASABLE. THERE WERE TWO RECIPIENTS WHO RECEIVED VALVES FROM THIS DONOR. BOTH, RPTR BELIEVES WERE CHILDREN. ONE CHILD DIED WITHIN 1 DAY WITH CONDUIT ONLY. DETAILS OF THIS OPERATION WERE SKETCHY, BECAUSE THE CHILD RECEIVED ONLY THE CONDUIT PORTION OF THE IMPLANT, AND NOT THE VALVE, SO THE HOSP DID NOT WANT TO DIVULGE ADDITIONAL INFORMATION. SINCE THE DEATH OCCURRED SO SOON AFTER IMPLANT, IT IS UNLIKELY THAT PSEUDOMONAS COULD HAVE BEEN THE CAUSE, BUT IT IS NOT KNOWN. (SEE 1008026.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE ALLOGRAFT TISSUE ALLOGRAFT LWR AMERICAN RED CROSS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death