BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM

    MDR report key: 1968586 · Received December 23, 2010

    Report

    Report Number
    1018233-2010-00147
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVAL NOTING A TEAR IN ONE MESH ARM. THE LOT HISTORY REVIEW DID NOT INDICATE ANYTHING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DIRECTIONS FOR USE STATE THE FOLLOWING: 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. ADD'L 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 BROKE DURING PLACEMENT. A SECOND MESH WAS PLACED DURING THE SAME PROCEDURE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS SYNTHETIC SUPPORT SYSTEM FTL C.R. BARD, INC. NA BMUH0023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK