BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SUPPORT SYSTEM

    MDR report key: 2092890 · Received May 11, 2011

    Report

    Report Number
    1018233-2011-00101
    Event Type
    Injury
    Date Received
    May 11, 2011
    Report Date
    January 7, 2016
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K063712
    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 IS UNKNOWN THEREFORE NO REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. THE INSTRUCTIONS FOR USE 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. (B)(4).

    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 SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, INCLUDING EXTREME PAIN AND EROSION OF HER INTERNAL BODILY TISSUES, HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES, AND SHE 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 39 YR Female Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM