BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE

    MDR report key: 437982 · Received January 7, 2003

    Report

    Report Number
    437982
    Event Type
    Malfunction
    Date Received
    January 7, 2003
    Date of Event
    December 26, 2002
    Report Date
    January 7, 2003
    Manufacturer
    TYCO HEALTHCARE LIMITED
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED SUBCUTANEOUS AIR IN CHEST WALL 7 HOURS AFTER CHEST TUBE PLACEMENT. CHANGED TO GLASS BOTTLE AND EVENTUALLY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE ALTITUDE DRAIN KDQ TYCO HEALTHCARE LIMITED * 02J681E

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other