BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3140919 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-02223
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    December 28, 2015
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    FTL
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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).

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231105 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR Mesh, surgical, polymeric FTL BARD SHANNON LIMITED NA HUSD2135R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention ARIS-TRANSOBTURATOR SLING SYSTEM| ARIS-TRANSOBTURATOR SLING SYSTEM