BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL BITE BLOCK

    MDR report key: 678045 · Received January 24, 2006

    Report

    Report Number
    MW1037831
    Event Type
    Malfunction
    Date Received
    January 24, 2006
    Date of Event
    January 21, 2006
    Report Date
    January 24, 2006
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BITE BLOCK USED IN THIS INTUBATED PT HAD CRACKED AND HAD BEEN DISLODGED FROM ITS PROPER POSITION. IT HAD MIGRATED DISTALLY, POSSIBLY TO THE OROPHARYNX. IT WAS COUGHED OUT BY THE PT APPROX ONE MINUTE FOLLOWING EXTUBATION. POTENTIAL FOR ASPIRATION AND CHOKING OR, IF SWALLOWED, INTESTIONAL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL BITE BLOCK BITE BLOCK JXL B&B MEDICAL TECHNOLOGIES 11160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other