BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONATAL ORAL CARE KIT

    MDR report key: 3032662 · Received March 28, 2013

    Report

    Report Number
    MW5029569
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    YORKS MEDICAL
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEONATAL ORAL CARE KIT CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127590 NEONATAL ORAL CARE KIT NEONATAL ORAL CARE KIT KXF YORKS MEDICAL * 093011

    Patients

    Seq Age Sex Outcome Treatment
    1