BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTA SST

    MDR report key: 2963561 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00148
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    August 6, 2009
    Report Date
    August 25, 2009
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    DSY
    PMA / PMN Number
    K020767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED GRAFT CONFIRMED THAT THERE WAS A TEAR, HOWEVER AFTER REPEATED ATTEMPTS TO GATHER MORE INFO NONE WAS FORTHCOMING. WITHOUT AN UNDERSTANDING OF THE TECHNIQUE APPLIED OR ANY/AND ALL COMPLICATIONS ENCOUNTERED IT IS DIFFICULT TO REPRODUCE THE EXACT SCENARIO WHICH OCCURRED AND THEREFORE DETERMINE ROOT CAUSE. A REVIEW OF THE QUALITY CONTROL RECORD FOR THIS LOT FOUND THAT NO ABNORMALITIES OR DEFECTS WERE NOTED.

    Description of Event or Problem · 1

    DURING EXPLANTATION THE GRAFT WAS TORN APPROX. 2MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460 ADVANTA SST DSY ATRIUM MEDICAL CORP. 25005 AF08710

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention