BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLLISTER ETAD

    MDR report key: 479891 · Received August 21, 2003

    Report

    Report Number
    1119193-2003-00006
    Event Type
    Other
    Date Received
    August 21, 2003
    Date of Event
    July 8, 2003
    Report Date
    August 20, 2003
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN ETAD WAS REMOVED AFTER 16 DAYS WEAR TIME. A DIME SIZE WOUND LOCATED BETWEEN THE UPPER LIP AND NOSE WAS OBSERVED. THE WOUND WAS CLEANSED AND SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLLISTER ETAD ORAL ENDOTRACHEAL TUBE ATTACHMENT DEVICE CBH HOLLISTER INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention