BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 3142134 · Received May 29, 2013

    Report

    Report Number
    1018233-2013-02231
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    March 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
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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 RISK 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

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED ANTERIOR AND POSTERIOR MESH EXPOSURE WITH SUBSEQUENT REMOVAL OF THE ANTERIOR AND POSTERIOR TRANSVAGINAL MESH, CONTINUED PELVIC PAIN, DYSPAREUNIA, VAGINAL PAIN, ABNORMAL VAGINAL BLEEDING, STENOTIC AND AN UNUSUALLY TENDER VAGINA REQUIRING EXAM UNDER ANESTHESIA, SUBSEQUENT SURGICAL REMOVAL OF TWO PERMANENT VAGINAL SUTURES WITH FINDINGS OF APPROXIMATELY FOUL SMELLING DRAINAGE UPON REMOVAL.

    Description of Event or Problem · 1

    COMPLAINT #: (B)(4). IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR #: 1018233-2013-02232.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235742 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR FTL BARD SHANNON LIMITED NA HUSK0106

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention AVAULTA SOLO ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM