BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 102007 · Received July 1, 1997

    Report

    Report Number
    MW1011602
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    January 16, 1997
    Report Date
    June 30, 1997
    Manufacturer
    MALLINCKRODT MEDICAL TPI, INC.
    Product Code
    BTR
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    #8 ENDOTRACHEAL TUBE CUFF DEFLATED DURING A CODE. PT. THEN BEGAN TO BREATH SPONTANEOUSLY ON OWN. NO ILL EFFECTS TO PT. MFR NOTIFIED. PACKAGING DISCARDED, UNABLE TO DETERMINE LOT#. TUBE ALSO DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK ENDOTRACHEAL TUBE #8 BTR MALLINCKRODT MEDICAL TPI, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening