BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLLISTER E-TAD

    MDR report key: 499262 · Received December 1, 2003

    Report

    Report Number
    1119193-2003-00009
    Event Type
    Other
    Date Received
    December 1, 2003
    Manufacturer
    HOLLISTER, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED PRESSURE SORE WHILE THE ETAD WAS WORN. PATIENT'S TEETH PUSHED COMPLETELY THROUGH UPPER LIP. WOUND REQUIRED SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER E-TAD ORAL ENDOTRACHEAL TUBE ATTACHMENT DEVICE CBH HOLLISTER, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention