BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BITE PROOF BITE BLOCK; UNIVERSAL BITE BLOCK

    MDR report key: 19744360 · Received July 12, 2024

    Report

    Report Number
    MW5157275
    Event Type
    Injury
    Date Received
    July 12, 2024
    Report Date
    July 11, 2024
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC.
    Product Code
    JAY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    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." DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738564 BITE PROOF BITE BLOCK; UNIVERSAL BITE BLOCK SUPPORT, BREATHING TUBE JAY B & B MEDICAL TECHNOLOGIES, INC. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female