BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BITEGARD BITE BLOCK

    MDR report key: 21686771 · Received March 25, 2025

    Report

    Report Number
    21686771
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 20, 2025
    Manufacturer
    TELEFLEX LLC
    Product Code
    BRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS INTUBATED AND BITE GUARD WAS PLACED TO PREVENT FROM BEING BIT. PART OF THE SOFTER MOLAR GUARD WAS ABLE TO BE BITTEN OFF BY THE PATIENT AND A PIECE WAS LODGED IN PHARYNX THAT WAS EVENTUALLY COUGHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114062 BITEGARD BITE BLOCK PROTECTOR, DENTAL BRW TELEFLEX LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Male