BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL BITE BLOCK

    MDR report key: 305176 · Received October 31, 2000

    Report

    Report Number
    305176
    Event Type
    Other
    Date Received
    October 31, 2000
    Date of Event
    October 16, 2000
    Report Date
    October 31, 2000
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    JXL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BITEBLOCK PLACED ON THE ENDOTRACHEAL TUBE SLIPPED BACK INTO THE OROPHARYNX. THERE IS A RAISED SHARP EDGE ON THE DEVICE WHICH LACERATED THE PT'S SOFT PALATE REQUIRING SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL BITE BLOCK UNIVERSAL BITE BLOCK (ADULT) JXL B&B MEDICAL TECHNOLOGIES * 990101

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other