BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC KING AIRWAY 2.5

    MDR report key: 5665964 · Received May 16, 2016

    Report

    Report Number
    MW5062364
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 16, 2016
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    CAE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    MEDICAL PRODUCT IS MISLABELED. THE AMBU CORP. THE PEDIATRIC KING 2.5 SUPRAGLOTTIC AIRWAY IS MISLABELED. THERE IS A DIFFERENCE BETWEEN THE PRODUCT LABEL AND THE INSTRUCTIONAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311815 PEDIATRIC KING AIRWAY 2.5 SUPRAGLOTTIC AIRWAY CAE KING SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1