BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1040188 · Received May 8, 2008

    Report

    Report Number
    1018233-2008-00030
    Event Type
    Injury
    Date Received
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. 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 NON-ABSORBABLE MESHES. BASELINE REPORT PREVIOUSLY FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS FOLLOWING ANTERIOR AND POSTERIOR PROCEDURES IN 2007, THE DOCTOR NOTED DISRUPTION OF THE SUTURE LINE TOWARD THE APEX OF THE ANTERIOR INCISION SITE. THE DOCTOR TRIMMED THE EXPOSED PORTION OF THE GRAFT AND NOTED THAT THE ANTERIOR AND POSTERIOR APICAL ARMS HAD BEEN OVER-TENSIONED. THE ARMS WERE CUT BUT NOT REMOVED FROM THE PATIENT. THE PATIENT HAS BEEN TREATED WITH ORAL ANTIBIOTICS. ESTROGEN CREAM, METROGEL (AN ANTIBIOTIC GEL), AND BETADINE DOUCHES. DURING THIS TIME FRAME, THE PATIENT ALSO DEVELOPED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PATIENT IS DESCRIBED AS HEALING AND PROGRESSING.

    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 UNK Required Intervention TOT