BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSO ETM UNIVERSAL BITEBLOCK

    MDR report key: 19469264 · Received June 4, 2024

    Report

    Report Number
    MW5155753
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 31, 2024
    Manufacturer
    ATTUNE MEDICAL / ADVANCED COOLING THERAPY, INC.
    Product Code
    PLA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS FOUND TO HAVE A PIECE OF TOOTH IN HER MOUTH. UNIVERSAL BITEBLOCK WAS USED FOR INTUBATION. PIECE OF TOOTH CAME FROM AND POINTS TO LEFT UPPER INCISOR WHICH IS PART OF A PERMANENT BRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6459 ENSO ETM UNIVERSAL BITEBLOCK ESOPHAGEAL THERMAL REGULATION AND GASTRIC SUCTIONING DEVICE PLA ATTUNE MEDICAL / ADVANCED COOLING THERAPY, INC. 199131423

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention