BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3060693 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01127
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    January 30, 2017
    Manufacturer
    BARD SHANNON LTD.
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATION 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

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01128.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156781 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR No Match OTP BARD SHANNON LTD. NA HUTF0676
    156782 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR No Match OTP BARD SHANNON LTD. NA HUTF0676

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM