BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1020719 · Received March 24, 2008

    Report

    Report Number
    1018233-2008-00019
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 28, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE INSTRUCTIONS FOR USE STATES THAT INFECTION IS A WELL KNOWN POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE SECTION LABELED ADVERSE REACTIONS THAT POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE. THE PRODUCT IS RECOMMENDED TO ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THE IMPLANTATION OF NONABSORBABLE MESHES. BASELINE REPORT PREVIOUSLY FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED THREE ABSCESSES FOLLOWING A PELVIC RECONSTRUCTION PROCEDURE IN 2007. THE ABSCESSES WERE DESCRIBED AS STERILE ABSCESSES WITH PUS AND DRAINAGE. THE LOCATIONS OF THE ABSCESSES WERE DESCRIBED AS TWO AT THE DISTAL ARMS TO THE INTROITUS, AND ONE AT THE PROXIMAL ARM ON THE PT'S RIGHT SIDE. THE PT WAS TREATED WITH ANTIBIOTICS. THE DOCTOR REMOVED THE IMPLANT IN 2008, AND SENT THE REMOVED IMPLANT MATERIAL TO HOSPITAL PATHOLOGY. ADD'L INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention