BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATOR, COTTON TIPPED 6IN STERILE

    MDR report key: 2033556 · Received March 6, 2011

    Report

    Report Number
    2033556
    Event Type
    Malfunction
    Date Received
    March 6, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 6, 2011
    Manufacturer
    CENTURION MEDICAL PRODUCTS
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COTTON TIP APPLICATORS: LOOSE COTTON FIBER, NO COTTON FIBER, OR WOOD SPLINTERS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLICATOR, COTTON TIPPED 6IN STERILE APPLICATOR, COTTON TIPPED 6IN STERILE KXG CENTURION MEDICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *