BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS DRY SUCTION WATER SEAL CHESTDRAIN

    MDR report key: 3561605 · Received November 7, 2013

    Report

    Report Number
    1219977-2013-00159
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Date of Event
    June 17, 2013
    Report Date
    October 11, 2013
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    CAC
    PMA / PMN Number
    K043140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON THE COMPLETED INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. RECALL INITIATED 11/07/2013 REFERENCE REPORT NUMBER: 1219977-10/24/2013-005-R.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT DURING REMOVAL OF PRODUCT FROM THE DRAIN CADDY, ATS ACCESS LINE CAME FREE FROM THE CHEST DRAIN. NO CUSTOMER ADVERSE OUTCOME REPORTED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576983 OASIS DRY SUCTION WATER SEAL CHESTDRAIN CAC ATRIUM MEDICAL CORPORATION 3650-100

    Patients

    Seq Age Sex Outcome Treatment
    1