BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3213355 · Received July 2, 2013

    Report

    Report Number
    1018233-2013-02694
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    January 12, 2016
    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
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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, WHICH MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-02692 AND 1018233-2013-02696.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302784 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR Mesh, surgical, polymeric FTL C.R. BARD, INC. (COVINGTON) NA CVRI0022

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM:| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYS - POSTERIOR| PRODUCT # 486201, LOT # CVRI0042| PRODUCT # BRD400HK, LOT# CVRI0018| PRODUCT # BRD400HK, LOT# CVRI0018| ALIGN TO URETHRAL SUPPORT SYSTEM,| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYS - POSTERIOR| PRODUCT # 486201, LOT # CVRI0042