BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 1053103 · Received May 20, 2008

    Report

    Report Number
    1053103
    Date Received
    May 20, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRP
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    AT THE END OF CATARACT SURGERY, SURGEON REMOVED HEAD BAR DRAPE, A COMPONENT IN OUR CATARACT CUSTOM PACK. IN POST OP FOLLOW-UP VISIT, PATIENT REPORTED BRUISING ON FOREHEAD. FOLLOW UP ON THIS AND ONE OTHER CASE REVEALED THAT BOTH PATIENTS WERE ELDERLY AND ON COUMADIN THERAPY.MANUFACTURER IS CHECKING TO SEE IF THERE WAS A CHANGE IN THE ADHESIVE USED IN THIS NEW LOT OF CUSTOM PROCEDURE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TRAY, SURGICAL LRP CARDINAL HEALTH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR OTHER| OTHER