BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM

    MDR report key: 3132597 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02002
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    November 17, 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
    GA, 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 STATED 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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. COMPLAINT # (B)(4). ASSOCIATED MDR 1018233-2013-01968.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218305 AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM Mesh, surgical, polymeric FTL BARD SHANNON LIMITED NA HUSC0117R

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention PELVILACE TO BIOURETHRAL SUPPORT SYSTEM | W/ HOOK NEEDLE| PELVILACE TO BIOURETHRAL SUPPORT SYSTEM| W/ HOOK NEEDLE