BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SUPPORT SYSTEM

    MDR report key: 2230398 · Received August 15, 2011

    Report

    Report Number
    1018233-2011-00193
    Event Type
    Injury
    Date Received
    August 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083839
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 IFU STATES UNDER PRECAUTIONS: "AVAULTA BIOSYNTHETIC 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 NON-ABSORBABLE MESHES. ACCEPTABLE SURGICAL PRACTICES SHOULD BE FOLLOWED FOR THE MANAGEMENT OF INFECTED OR CONTAMINATED WOUNDS. THE AVAULTA BIOSYNTHETIC MESH IMPLANTATION PROCEDURE REQUIRES DILIGENT ATTENTION TO ANATOMICAL STRUCTURE AND CARE TO AVOID PUNCTURE OF LARGE VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR OTHER VISCERA DURING NEEDLE PASSAGE. EXCESSIVE TENSION SHOULD BE AVOIDED ON THE AVAULTA BIOSYNTHETIC MESH AND SUTURE ATTACHMENT POINTS TO ACCOUNT FOR WOUND SHRINKAGE DURING THE HEALING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SERIOUS BODILY INJURIES INCLUDING EXTREME PAIN, RECURRENT INFECTIONS, EROSION OF HER INTERNAL TISSUES, DYSPAREUNIA, SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING AND HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES AND HAS SUSTAINED PERMANENT INJURIES.

    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