BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BITE-BLOCK

    MDR report key: 11902 · Received March 9, 1994

    Report

    Report Number
    MW1001002
    Event Type
    Injury
    Date Received
    March 9, 1994
    Date of Event
    January 18, 1994
    Report Date
    February 18, 1994
    Manufacturer
    SONTEK MEDICAL, INC.
    Product Code
    BRW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED LEAK IN ETT CUFF. STAFF UNABLE TO INJECT AIR THROUGH PILOT BALLOON. PT EXTUBATED AND REINTUBATED. PILOT BALLOON TUBE FOUND KINKED UNDER BITE BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BITE-BLOCK BRW SONTEK MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention