BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL ASPIRATOR

    MDR report key: 35090 · Received August 9, 1996

    Report

    Report Number
    MW4001430
    Event Type
    Injury
    Date Received
    August 9, 1996
    Report Date
    April 3, 1996
    Manufacturer
    SAFETY 1ST, INC.
    Product Code
    KYZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A NASAL ASPIRATOR (CLEAR PLASTIC) WAS USED TO SUCTION A BABY'S MOUTH. THE PLASTIC TIP BROKE OFF AND BECAME CAUGHT IN THE CHILD'S TRACHEA. THE CHILD WAS TAKEN TO A HOSP ER, BY AN EMERGENCY MEDICAL TECH (EMT) AMBULANCE, THE CHILD WAS THEN ADMITTED TO THE HOSP AFTER REMOVAL OF THE TIPS AND SUFFERED TRAUMA, AS A RESULT OF THE TIP BEING CAUGHT IN TRACHEA. DR FEELS A WARNING LABEL IS NEEDED TO PREVENT ORAL USE. NASAL ASPIRATOR INCLUDED IN A BOXED KIT THAT ALSO INCLUDES A THERMOMETER, SCISSORS, ORAL MEDICINE SYRINGE, SPOON AND NAIL CLIPPERS FOR INFANT CARE. DR STATED THAT SHE BELIEVED THERE SHOULD BE A WARNING STATEMENT TO CAUTION PEOPLE NOT TO USE THIS PARTICULAR NASAL ASPIRATOR TO SUCTION FROM A BABY'S MOUTH, BECAUSE OF THE POTENTIAL FOR THE PLASTIC TIP TO COME OFF AS IT DID IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL ASPIRATOR NASAL ASPIRATOR KYZ SAFETY 1ST, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO