BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA VS

    MDR report key: 2963510 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00156
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    May 6, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DYF
    PMA / PMN Number
    K992441
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED AND FOUND THE GRAFT MET ALL SPECIFICATIONS. THE EXPLANTED GRAFT SEGMENT WAS VISUALLY EXAMINED. NO HOLES, TEARS OR PERFORATIONS WERE FOUND IN THE GRAFT AND NO TISSUE INGROWTH WAS OBSERVED. WITH LIMITED INFO ON THE PATIENT AND PROCEDURE, IT IS DIFFICULT TO DETERMINE AN EXACT CAUSE OF THE SEROMA.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED AND FOUND THE GRAFT MET ALL SPECIFICATIONS. THE EXPLANTED GRAFT SEGMENT WAS VISUALLY EXAMINED. NO HOLES, TEARS OR PERFORATIONS WERE FOUND IN THE GRAFT AND NO TISSUE INGROWTH WAS OBSERVED. WITH LIMITED INFO ON THE PATIENT AND PROCEDURE, IT IS DIFFICULT TO DETERMINE AN EXACT CAUSE OF THE SEROMA.

    Description of Event or Problem · 1

    THE GRAFT WAS REMOVED DUE TO SEROMA FORMATION AND INFECTIVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569 ADVANTA VS DYF ATRIUM MEDICAL CORP. 22616 AJ21609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention