BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OASIS PEDI DRY DRAIN

    MDR report key: 2963674 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00182
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    October 19, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    CAC
    PMA / PMN Number
    K043140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATRIUM COULD NOT CONFIRM THE COMPLAINT. PRODUCT WAS NOT RETURNED FOR AN EVAL AND A LOT HISTORY REVIEW COULD NOT BE COMPLETED SINCE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    HOOKED UP TO DRY SUCTION, NO FLUCTUATIONS AT ALL, PT GETTING WORSE, DISCONNECTED PUT IN A SYRINGE EVACUATED LOTS OF AIR IN THE CHEST TUBE ITSELF, CONNECTED OCEAN DRAIN AND WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421 OASIS PEDI DRY DRAIN CAC ATRIUM MEDICAL CORP. 3612-100E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention