BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 487915 · Received September 23, 2003

    Report

    Report Number
    MW1029645
    Event Type
    Other
    Date Received
    September 23, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 19, 2003
    Manufacturer
    *
    Product Code
    LMO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIMARY GRAFT FAILURE ON TRANSPLANTED TISSUE. FAILURE NOT RELATED TO DONOR TISSUE. TISSUE IMPORTED FROM A PT WHO DIED FROM RENAL FAILURE. CORNEAS WERE TRANSPLANTED (PKP) TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LMO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Other