BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1033836 · Received April 24, 2008

    Report

    Report Number
    1018233-2008-00024
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    February 21, 2008
    Report Date
    April 24, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 EROSION 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 PROD 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.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO ISSUES REPORTED WITH THIS PT. IT WAS REPORTED THAT FOLLOWING ANTERIOR, POSTERIOR, AND TOT REPAIR PROCEDURES IN LATE 2007, THE PT EXPERIENCE PAIN ON HER LEFT BUTTOCK, A FOUL DISCHARGE, AND DIFFICULTY SITTING. DURING A POSTERIOR IMPLANT REMOVAL PROCEDURE IN 2008, THE DOCTOR NOTED EROSION OF THE ANTERIOR IMPLANT AND REMOVED THE ANTERIOR IMPLANT AS WELL. THE PT WAS DESCRIBED AS DOING FINE FOLLOWING THE REMOVAL OF THE IMPLANT.

    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 43 YR Required Intervention TOT REPAIR.| AVAULTA PLUS ANTERIOR SYNTHETIC SUPPORT SYSTEM