BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 974076 · Received January 2, 2008

    Report

    Report Number
    1018233-2007-00092
    Event Type
    Injury
    Date Received
    January 2, 2008
    Report Date
    January 2, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. INFECTION IS A WELL KNOWN POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE. THE IFU WHICH ACCOMPANIES EACH DEVICE STATES PROCEDURE. THE IFU 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 APPROX. 4-6 WEEKS FOLLOWING A POSTERIOR PROCEDURE, THE PT DEVELOPED GLUTEAL ABSCESSES. THE PT WAS DESCRIBED AS DOING VERY WELL UNTIL THEN. THE DOCTOR STATED THAT THE ABSCESS SEEMS TO BE RUNNING FROM BENEATH THE PERI-ANAL SKIN INCISION, UP ALONG THE DISTAL TRACT. THE PT WAS PLACED ON KEFLEX AND FLAGYL. THE PT WILL BE EXAMINED IN 2007. 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 UNK YR Required Intervention