BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3223487 · Received July 9, 2013

    Report

    Report Number
    1018233-2013-02785
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    October 12, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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). 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.

    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.

    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.

    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

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-02786.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED A DISRUPTED ANTERIOR DEFECT, SURGICAL PROCEDURE FOR REAPPROXIMATION OF ANTERIOR WALL, VAGINAL BLEEDING, EXAM UNDER ANESTHESIA, REMOVAL OF INFECTED MESH, ANTERIOR INCISION IN THE VAGINA WAS COMPLETELY SEPARATED, UNDERLYING MESH WAS EXPOSED, MALODOROUS, GIVEN TWO UNITS OF PACKED RED BLOOD CELLS, URGENCY, BURNING SENSATION DURING URINATION, DYSURIA AND STRESS URINARY INCONTINENCE.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLEEDING, LARGE BLOOD CLOT IN THE VAGINA, CLOSURE OF VAGINAL MUCOSA WITH FINDING OF INFECTED MESH, CONSTIPATION, MIXED INCONTINENCE, URGE INCONTINENCE, FREQUENT AND CHRONIC URINARY TRACT INFECTIONS, CHRONIC PAIN, RECURRENCE OF PROLAPSE AND URINARY RETENTION.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PAIN WITH URINATION, LOSS OF URINARY CONTROL, FOREIGN BODY IN PATIENT, AND NONSURGICAL INTERVENTIONS.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED PELVIC ORGAN PROLAPSE, UNSPECIFIED PHYSICAL LIMITATIONS, CYSTOCELE, HYPOTENSION AND LOW BLOOD PRESSURE, VAGINAL AND BLADDER INFECTIONS, VAGINAL PAIN, EDEMA, FLUID RETENTION, THICKENED VAGINAL MUCOSA, MALODOROUS EXUDATE, LEAKAGE, HEMORRHAGE, SORENESS, FATIGUE, PRESSURE, ABDOMINAL STRAINING, ABDOMINAL PAIN, DISCOMFORT, AND CYST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313728 PAVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR OTP C.R. BARD, INC. (COVINGTON) NA CVRF0066

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention PROD # 486201, LOT # CVRF0067