BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCCUGRAFT SOFT

    MDR report key: 3063711 · Received April 12, 2013

    Report

    Report Number
    1219977-2013-00038
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K000499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE IS CURRENTLY UNDER EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICE WAS FOUND TO HAVE MET ALL SPECIFICATIONS WITHOUT ANY DEVIATIONS.

    Description of Event or Problem · 1

    THE GRAFT WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157459 VASCCUGRAFT SOFT DSY ATRIUM MEDICAL CORP. V1101514 10800952, 10815773

    Patients

    Seq Age Sex Outcome Treatment
    1