BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1934148 · Received December 8, 2010

    Report

    Report Number
    1018233-2010-00154
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 11, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ONE OF THE GRAFT ARMS WAS TORN. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE STATES: "APPLY TRACTION TO DRAW THE PROXIMAL (INFERIOR) ARMS OF THE GRAFT INTO THE DESIRED POSITION SUCH THAT THE PROXIMAL END OF THE CENTRAL GRAFT IS POSITIONED AT THE VAGINAL APEX. BE SURE THE GRAFT IS TENSION-FREE. ENSURE THE CENTRAL GRAFT IS POSITIONED UNDER THE BLADDER WITHOUT EXCESSIVE TENSION. THE MESH SHOULD BE SUFFICIENTLY ANCHORED TO STABILIZE IT DURING TISSUE INGROWTH. ADDITIONAL SUTURES MAY BE USED TO SECURE THE MESH TENSION-FREE. CAUTION: EXCESSIVE TENSION SHOULD BE AVOIDED ON THE MESH AND SUTURE ATTACHMENT POINTS TO ACCOUNT FOR WOUND SHRINKAGE DURING THE HEALING PROCESS." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARM WAS BROKEN BY USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM FTL C.R. BARD, INC. NA BMUE0016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA