BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-28-QL-PFO

    MDR report key: 381828 · Received March 11, 2002

    Report

    Report Number
    1222632-2002-00007
    Event Type
    Injury
    Date Received
    March 11, 2002
    Date of Event
    December 31, 2001
    Report Date
    March 8, 2002
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS FORWARDED TO THE COMPANY. IN 2001, PATIENT RECEIVED THE DEVICE. SUBSEQUENTLY, IN THE NEXT MONTH A THROMBUS WAS DETECTED. ANGIOJET A FEW WEEKS LATER SHOWED THAT THE LEFT SIDE THROMBUS HAD IMPROVED BUT THE RIGHT ATRIAL THROMBUS WAS STILL INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-28-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-28-QL-PFO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention