BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEUR-EVAC INFANT SINGLE COLLECTION W/DRY SUCTION

    MDR report key: 143678 · Received January 8, 1998

    Report

    Report Number
    1221601-1998-00001
    Event Type
    Injury
    Date Received
    January 8, 1998
    Report Date
    January 8, 1998
    Manufacturer
    DEKNATEL, INC.
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR ALLEGES PNEUMOTHORAX MAY BE PROVOKED BY HIGH NEGATIVITY RELIEF VALVE WHEN CHILDREN ARE ON PEEP (MECHANICAL VENTILATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR-EVAC INFANT SINGLE COLLECTION W/DRY SUCTION CHEST DRAINAGE SYSTEM KDQ DEKNATEL, INC. A-6020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening