BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3233900 · Received July 16, 2013

    Report

    Report Number
    1018233-2013-02836
    Event Type
    Injury
    Date Received
    July 16, 2013
    Report Date
    October 6, 2016
    Manufacturer
    C.R. BARD, INC.
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    (B)(4) CORRECTION: COMMON DEVICE NAME. 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

    COMPLAINT #(B)(4). IT WAS REPORTED IN THE PATIENT'S PLAINTIFF FACT SHEET THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED EXTREME PAIN THROUGH HER PELVIC AND VAGINAL REGIONS, AS WELL AS EXCRUCIATING PAIN DURING INTERCOURSE. THE MESH ERODED AND EXTRUDED FROM HER BODY. SHE SUFFERED FROM THE PAIN AND DISCOMFORT OF MULTIPLE REVISION SURGERIES TO CORRECT AND REMOVE PORTIONS OF THE MESH, BLADDER INFECTIONS, AND SEVERE URINARY INCONTINENCE. SHE ALSO SUFFERED BY PSYCHOLOGICALLY AND EMOTIONALLY. ASSOCIATED MDRS: 1018233-2012-00084, 1018233-2012-00081.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, EXPOSED GRAFT, "LOOKS LIKE GRAFT HAS WORKED ITS WAY DOWN" LEFT FLANK PAIN, FREQUENCY, SLING, GRAFT REJECTION (FAILURE OF IMPLANT), MESH EROSION, CYSTITIS CYSTICA (INFLAMMATION), "CHRONICALLY INFECTED WOODY TISSUE", MESH REMNANTS, MIDLINE FIRM TISSUE, SUBURETHRAL ABSCESS, CONCENTRATED URINE, DECREASED POTASSIUM LEVELS (ELECTROLYTE IMBALANCES), URGENCY, BACK PAIN, ABDOMINAL PAIN, CYSTOCELE (PROLAPSE), ANXIETY, DEPRESSION, PELVIC, VAGINAL PAIN, STRESS INCONTINENCE, NAUSEA, UNSPECIFIED URINARY SYMPTOMS, URINARY TRACT INFECTION, DYSPAREUNIA, PROBLEMS URINATING, LEAKAGE, TEARFUL (EMOTIONAL CHANGES), ODOR, ELEVATED TEMPERATURE, "SUTURES BROKE DOWN", VOMITING, INFECTED TISSUE, VAGINAL DISCHARGE, ADHERENT BENIGN FIBROVASCULAR, SKELETAL MUSCLE TISSUE CONTAINING FOREIGN BODY GIANT CELL REACTION (ADHESIONS, FIBROSIS, FOREIGN BODY IN PATIENT), PNEUMONIA, ELEVATED BLOOD SUGARS, NOCTURIA, DYSURIA, MESH EXTRUSION, HOT FLASHES, DOUBLE VOIDING, POST VOID DRIBBLING AND NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330158 AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM OTP C.R. BARD, INC. NA CVSF0022

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM