BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR

    MDR report key: 3213781 · Received July 3, 2013

    Report

    Report Number
    1018233-2013-02689
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    August 29, 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
    FL, 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)

    Description of Event or Problem · 1

    (B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR 1018233-2013-02690.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EROSION, PAIN DURING INTERCOURSE, URINE LEAKAGE, BLOOD LOSS, URINARY TRACT INFECTION, LOW BACK PAIN, ELEVATED BLOOD PRESSURE, BODY ACHES, FREQUENCY, URGENCY, BILATERAL COSTOVERTEBRAL ANGLE TENDERNESS, SUPRAPUBIC PRESSURE WITH PALPATION, BACTERIA, EPITHELIALS, WHITE BLOOD CELLS IN URINE, PELVIC PAIN, LUMBAR RADICULOPATHY, FATIGUE, LOSES CONTROL OF URINE AND NONSURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305092 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR OTP C.R. BARD, INC. NA CVRFX094

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention LOT CVRFX091, PRODUCT # 486201