BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO POSTERIOR SYNTHETIC SUPPORT SYSTEM

    MDR report key: 3213822 · Received July 3, 2013

    Report

    Report Number
    1018233-2013-02687
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    January 21, 2016
    Manufacturer
    BARD SHANNON LIMITED
    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

    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, 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.

    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 MDR #'S: 1018233-2013-02686 AND 1018233-2013-02688.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MIXED URINARY INCONTINENCE, PREDOMINANTLY STRESS INCONTINENCE, PERIURETHRAL COLLAGEN INJECTION IN 2008, BACTRIM BUT THE MEDICATION MADE HER NAUSEAS, SHE ELECTED TO HAVE A SECOND URETHRAL SLING PLACED (2009).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306396 AVAULTA SOLO POSTERIOR SYNTHETIC SUPPORT SYSTEM FTL BARD SHANNON LIMITED NA HUSC0113

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM:| LOT #CVSA0114| PRODUCT #486100, LOT #HUSD2136R