BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 2980508 · Received February 22, 2013

    Report

    Report Number
    1018233-2013-00495
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    January 4, 2017
    Manufacturer
    BARD SHANNON LIMITED
    Product Code
    OTP
    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 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 REACTION: "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 VISCERAL MAY OCCUR DURING NEEDLE PASSAGE." (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00496, 1018233-2013-00497 AND 1018233-2013-00498.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77299 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR No Match OTP BARD SHANNON LIMITED NA HUSL0147
    77436 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR No Match OTP BARD SHANNON LIMITED NA HUSL0147

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention ALIGN S URETHRAL SUPPORT SYSTEM| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM: POSTERIOR| AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM: POSTERIOR| ALIGN S URETHRAL SUPPORT SYSTEM