BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SUPPORT SYSTEM

    MDR report key: 1971489 · Received January 21, 2011

    Report

    Report Number
    1018233-2011-00015
    Event Type
    Injury
    Date Received
    January 21, 2011
    Report Date
    December 22, 2010
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED AND THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE DEVICE REMAINS IMPLANTED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE REACTIONS SECTION: "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 INSTRUCTIONS FOR USE STATES UNDER PRECAUTIONS: "THE MESH SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THE IMPLANTATION OF NONABSORBABLE MESHES." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE DEVICE THAT WAS PLACED IN 2007 BECAME ADHERED TO HER BOWEL CAUSING AN OBSTRUCTION. THE PATIENT COMPLAINS OF CHRONIC ABDOMINAL PAIN AND TAKES ORAL ANTIBIOTICS, OPIOID PAIN-RELIEVERS, AND VAGINAL DOUCHES FOR INFECTION AND BLEEDING. THE DEVICE COULD NOT BE REMOVED TO RELIEVE THE OBSTRUCTED BOWEL THEREFORE, REQUIRING PLACEMENT OF AN ENTERAL FEEDING TUBE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION AND HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention