BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM

    MDR report key: 3192028 · Received June 20, 2013

    Report

    Report Number
    1018233-2013-02479
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    December 19, 2016
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    OTP
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THE 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).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED FAILURE (FAILURE OF IMPLANT), DISCOMFORT, CONTINUED STRESS INCONTINENCE, PAIN, UNSPECIFIED URINARY PROBLEMS, BLEEDING AND REQUIRED ADDITIONAL SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED TRANSIENT POST-OPERATIVE HYPOTENSION DUE TO PATIENT CONTROLLED ANALGESIC PUMP, LEUKOCYTE ESTERASE IN URINE, BLOOD IN URINE (HEMATURIA), STRESS URINARY INCONTINENCE, OVERACTIVE BLADDER, CYSTOCELE/RECTOCELE (PROLAPSE), INTRINSIC SPHINCTER DYSFUNCTION, URINARY FREQUENCY, NOCTURIA, URINE LEAKAGE, GASTROINTESTINAL REFLUX DISEASE, PAIN, DISCOMFORT, NEED TO STRAIN TO COMPLETELY EMPTY BLADDER, PELVIC PAIN, TAUGHT/TENDER MESH ARMS BILATERALLY, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-02478, 1018233-2013-02480 AND 1018233-2013-02481.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281462 AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM OTP BARD SHANNON LIMITED NA HUUA0194

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention LOT # HUUA0192| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM POSTERIOR,| 486200| LOT # 09B05-8.| PELVISOFT ACELLULAR COLLAGEN BIOMESH, 481068,