BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CARDIOSEAL

    MDR report key: 510119 · Received February 3, 2004

    Report

    Report Number
    1222632-2004-00001
    Event Type
    Injury
    Date Received
    February 3, 2004
    Date of Event
    December 12, 2003
    Report Date
    February 3, 2004
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN AT THE USER FACILITY REPORTED THAT PATIENT'S IMPLANTING PHYSICIAN RECEIVED INFO FROM AN OUTSIDE HOSPITAL THAT PATIENT WHO RECEIVED A CARDOSEAL IN 04/2002 PRESENTED WITH STROKE IN 12/2003 AND THAT ECHO REVEALED A POSSIBLE THROMBUS. TWO DAYS LATER USER FACILITY RECEIVED CALL THAT THE DEVICE WAS EXPLANTED AND THAT A MASS WAS OBSERVED ON THE DEVICE. PATIENT REPORTED TO BE IN STABLE CONDITION - AWAITING ADDITIONAL INFO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R