BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2455626 · Received February 13, 2012

    Report

    Report Number
    2455626
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 13, 2012
    Manufacturer
    NATIONAL HOSPITAL PACKAGING
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS USING STERILE 3 INCH APPLICATORS AND NOTED SHEDDING OF FINE WOOD SLIVERS. TWO PIECES FELL INTO PATIENT'S EYE DURING THE PROCEDURE. THE DOCTOR RETRIEVED BOTH PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * COTTON BUDS, 3 INCH KXF NATIONAL HOSPITAL PACKAGING 12/PKG #13-002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES