BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLE SALINE PLUS

    MDR report key: 3845853 · Received May 28, 2014

    Report

    Report Number
    MW5036399
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    CHUCH & DWIGHT
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER STATED THAT SHE FOLLOWED THE DIRECTIONS FOR USING THE SWAB WHICH IS TO BEND THE SWAB AT THE RING, SO THAT THE SOLUTION CAN FLOW THROUGH. THE CONSUMER HAD THE BABY LYING DOWN AND WAS SWABBING THE BABY'S NOSE WHEN ONE END OF THE COTTON SWAB FELL ONTO THE BABY'S MOUTH. SHE WAS ABLE TO GET THE TIP OUT OF THE BABY'S MOUTH. THE CHILD WAS NOT INJURED. THE CONSUMER STATED THAT THE TIPS HAS FALLEN OFF OF THE STEMS SEVERAL TIMES BEFORE WHEN IT WAS BENT TO START THE SOLUTION. THE CONSUMER CALLED THE MFR AND ADVISED THEM OF THE INCIDENT. THE CONSUMER WAS ADVISED THAT THEY DID NOT NEED TO BE INVOLVED. THE CONSUMER WAS OFFERED A REFUND. THE SWAB HAS A COLORED RING AROUND THE TIP. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2014, THIS DATE IS AN ESTIMATE. THE PRODUCT WAS NOT MANAGED BEFORE THE INCIDENT. THE PRODUCT WAS NOT MODIFIED BEFORE THE INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314702 SIMPLE SALINE PLUS NASAL SWAB FOR BABIES KXF CHUCH & DWIGHT

    Patients

    Seq Age Sex Outcome Treatment
    1