BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL OCL-028

    MDR report key: 302095 · Received October 27, 2000

    Report

    Report Number
    1222632-2000-00014
    Event Type
    Injury
    Date Received
    October 27, 2000
    Date of Event
    September 4, 2000
    Report Date
    October 27, 2000
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED STUDY DEVICE IN 2000. ONE MONTH LATER, PT CALLED THE OFFICE TO REPORT HOSPITALIZATION FOR THE TREATMENT OF ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL OCL-028 CARDIOSEAL MLV NMT MEDICAL, INC. OCL-028-PFO 0005180

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization