BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 487917 · Received September 23, 2003

    Report

    Report Number
    MW1029644
    Event Type
    Other
    Date Received
    September 23, 2003
    Date of Event
    September 9, 2003
    Report Date
    September 23, 2003
    Manufacturer
    *
    Product Code
    LMO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIMARY GRAFT FAILURE AFTER TRANSPLANT OF CORNEA TISSUE. GRAFT FAILURE NOT RELATED TO DONOR TISSUE. DONOR DIED OF AMI. DONATED CORNEA'S TO PT FOR PKP TRANSPLANT. PT DIAGNOSED WITH BULLOUS KERATOPATHY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other