BEUDAMED
    FDA Adverse Event Other Summary report: N

    B & B MEDICAL TECHNOLOGIES INC.

    MDR report key: 299723 · Received October 5, 2000

    Report

    Report Number
    MW1020114
    Event Type
    Other
    Date Received
    October 5, 2000
    Date of Event
    September 28, 2000
    Report Date
    October 5, 2000
    Manufacturer
    B & B MEDICAL TECHNOLOGIES INC.
    Product Code
    JXL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT CAUSED POSSIBLE GUM DAMAGE DUE TO BITING AND GRINDING DOWN ON PRODUCT. THE TOP OF THE BITE TUBE HAS A PIECE THAT PROTRUDES OUTWARD, THIS PIECE WAS BEING "CHEWED" ON, CAUSING IRRITATION TO THE TEETH AND GUMS. THE TUBE PERFORMED ITS DESCRIBED FUNCTION PROTECTING THE ENDOTRACHEAL TUBE, BUT SEEMS EXTREMELY RIGID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 B & B MEDICAL TECHNOLOGIES INC. UNIVERSAL BITE BLOCK JXL B & B MEDICAL TECHNOLOGIES INC. UNIVERSAL BITE BLOCK 960725

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO Other