BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM

    MDR report key: 1920118 · Received December 8, 2010

    Report

    Report Number
    1018233-2010-00135
    Event Type
    Injury
    Date Received
    December 8, 2010
    Report Date
    December 9, 2015
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K083839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    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 PROLAPSED. 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'S ATTORNEY THAT AS A RESULT OF HAVING THE MESH IMPLANTED, THE PT HAS EXPERIENCED SERIOUS BODILY INJURIES, INCLUDING EXTREME PAIN, INFECTION OF HER INTERNAL BODILY TISSUES, DYSPAREUNIA, SIGNIFICANT MENTAL PAIN AND SUFFERING, UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES, AND HAS SUSTAINED PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237301 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM FTL C.R. BARD, INC. NA HUSD2136R

    Patients

    Seq Age Sex Outcome Treatment
    1