BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-33-QL-PFO

    MDR report key: 375890 · Received February 8, 2002

    Report

    Report Number
    1222632-2002-00002
    Event Type
    Injury
    Date Received
    February 8, 2002
    Date of Event
    January 23, 2002
    Report Date
    February 4, 2002
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO CO'S CLINICAL MARKET SPECIALIST, THE FOLLOWING TOOK PLACE. "DURING A PROCEDURE PHYSICIAN HAD NO ECHO ONLY FLUORO AND THE DEVICE WAS MISPLACED. THE DEVICE WAS RETRIEVED WITH A SNARE TO THE GROIN AREA WHERE IT WAS SURGICALLY REMOVED. PATIENT IS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-33-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-33-QL-PFO 0112136

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention