BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEUR-EVAC PLUS CHEST TUBE DRAIN

    MDR report key: 24312 · Received August 11, 1995

    Report

    Report Number
    MW1006691
    Event Type
    Malfunction
    Date Received
    August 11, 1995
    Date of Event
    July 1, 1995
    Report Date
    August 8, 1995
    Manufacturer
    DEKNATEL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON OPENING PACKAGE, BOTTOM OF DEVICE WAS BROKEN OFF. PLASTIC OVER AIR LEAK METER WAS ALSO CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC PLUS CHEST TUBE DRAIN CHEST TUBE DRAIN KDQ DEKNATEL, INC. A 9250

    Patients

    Seq Age Sex Outcome Treatment
    1 *