BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 3121864 · Received May 15, 2013

    Report

    Report Number
    1018233-2013-01728
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    November 10, 2015
    Manufacturer
    C.R. BARD, INC (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECS 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

    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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01729. (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED OOZING, BLEEDING, EROSION OF VAGINAL MESH, EXPOSED MESH, BLEEDING AFTER INTERCOURSE, UNCONTROLLED URINE WITH SEVERE COUGHING, LOWER ABDOMINAL/PELVIC PAIN, PAIN ON INTERCOURSE/DYSPAREUNIA, LEAKAGE, BLADDER AND RECTAL SPASMS (MUSCLE SPASMS), I-II GRADE CYSTOCELE (PROLAPSE), CHRONIC COUGH, HOT FLASHES, PELVIC PRESSURE, INFLAMMATION, VAGINAL DISCHARGE AND DISCOMFORT, URINARY INCONTINENCE, FREQUENT YEAST INFECTIONS, FEELING A MASS AROUND ANAL AREA, THROMBOSED HEMORRHOID, CLOTS, SORENESS AROUND STAB INCISIONS, ADHESIONS, ANXIETY, INSOMNIA, HYPERTENSION, BLOOD PRESSURE, TENDERNESS OVER TIP OF COCCYX, WEIGHT LOSS, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215010 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR FTL C.R. BARD, INC (COVINGTON) NA CVSA0026

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention