BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KC 300

    MDR report key: 4289666 · Received November 14, 2014

    Report

    Report Number
    4289666
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 14, 2014
    Manufacturer
    KIMBERLY CLARK
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF WERE PULLING MASKS OUT OF THE BOX OF FACE SHIELDS AND NOTED THAT THERE WAS A BROWN DROPPING LODGED IN THE FACE PORTION OF ONE OF THE MASKS. STAFF NOT ABLE TO IDENTIFY WHAT THE ITEM WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738996 KC 300 KIMBERLY CLARK FLUIDSHIELD FRG KIMBERLY CLARK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *