BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 2930376 · Received January 22, 2013

    Report

    Report Number
    1018233-2013-00161
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    October 4, 2016
    Manufacturer
    C.R. BARD, INC.(COVINGTON)
    Product Code
    OTP
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-00160.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29651 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC.(COVINGTON) NA CVRF0111
    29680 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC.(COVINGTON) NA CVRF0111

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM| AVAULTA SOLO ANTERIOR SYNTHETIC SUPPORT SYSTEM