BEUDAMED
    FDA Adverse Event Other Summary report: N

    THORA SEALIII ATS CAPABILITY

    MDR report key: 484735 · Received September 18, 2003

    Report

    Report Number
    1310379-2003-00009
    Event Type
    Other
    Date Received
    September 18, 2003
    Date of Event
    September 3, 2003
    Report Date
    September 18, 2003
    Manufacturer
    TYCOHEALTHCARE / KENDALL
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER HAD A PROBLEM WITH A THORA-SEAL III. ACCORDING TO THE CUSTOMER "THORA-SEAL III CHEST TUBE WAS PLACED FOR PNEUMOTHORAX IN 2003. THE NEXT DAY PATIENT WAS EXPERIENCING INCREASE IN DIFFICULTY BREATHING AND IT WAS DISCOVERED THAT THE CHEST TUBE HAD BEEN INADVERTENTLY CLAMPED OFF. IT COULD HAVE HAPPENED DURING TRANSPORT TO DIAGNOSTIC IMAGING OR DURING PATIENT CARE ON THE NURSING UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORA SEALIII ATS CAPABILITY CHEST DRAINAGE SET CAC TYCOHEALTHCARE / KENDALL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other