BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL COTTON TIPPED APPLICATOR

    MDR report key: 1932237 · Received December 3, 2010

    Report

    Report Number
    3004605321-2010-00005
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S QUALITY ASSURANCE AND QUALITY CONTROL STAFF FOUND DURING THE DEVICE INSPECTION, THAT THE COTTON TIPPED APPLICATOR IS NOT RECOMMENDED FOR USE IN THE EYE AREA DUE TO THE POSSIBILITY OF LINTING. A MORE APPLICABLE ITEM WOULD BE AN EYE SPEAR WHICH IS SPECIFICALLY MANUFACTURED FOR USE IN THE EYE AREA. THE CUSTOMER WAS APPRISED OF THIS FINDING AND USE RECOMMENDATION AND THE INFORMATION WAS ADDED TO COTTON TIPPED APPLICATOR LABELS AND LABELING AS WELL.

    Description of Event or Problem · 1

    THE USER FACILITY HAD A FEW INSTANCES WHERE THE COTTON TIPPED APPLICATOR UNRAVELED AND LEFT LINT OR GOT LINT STUCK IN PTS' EYES. THERE WAS NO SPECIFIC PT NOTED TO HAVE BEEN AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL COTTON TIPPED APPLICATOR COTTON TIPPED APPLICATOR KXG DEROYAL INDUSTRIES, INC. 21707460

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R