BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SUPPORT SYSTEM

    MDR report key: 1991008 · Received February 10, 2011

    Report

    Report Number
    1018233-2011-00012
    Event Type
    Injury
    Date Received
    February 10, 2011
    Report Date
    January 4, 2016
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 ACCOMPANY EACH DEVICE STATE 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 STATE 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).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE REACTIONS: 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. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MASSIVE ENTEROCELE, RECURRENT VAGINAL VAULT PROLAPSE, EXPOSED VAGINAL MESH, LAPAROSCOPY, EXPLORATORY LAPAROTOMY WITH SACRAL COLPOPEXY, EXCISION OF EXPOSED VAGINAL MESH, KIDNEY STONE, VAGINAL BLEEDING, DISCHARGE, INFLAMED VAGINAL MUCOSA, THIRD DEGREE ENTEROCELE, POSTMENOPAUSAL, ATROPHIC VAGINITIS, CONSTIPATION, VAGINAL FIBROSIS, PELVIC AND VAGINAL PRESSURE, RECTAL PRESSURE, PERSISTENT HEMATURIA, DYSURIA, INCOMPLETE BLADDER EMPTYING, URGE INCONTINENCE AND VAGINAL DRYNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, SHE HAS SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME PAIN, INFECTION, EROSION OF HER INTERNAL BODILY TISSUE, SIGNIFICANT MENTAL PAIN AND SUFFERING AND SUSTAINED PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA SUPPORT SYSTEM AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR FTL C.R. BARD, INC. NA CVRL0017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention