BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 2970980 · Received February 15, 2013

    Report

    Report Number
    1018233-2013-00423
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    October 24, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    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 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 INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-00425 AND 1018233-2013-00424.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69498 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC. (COVINGTON) -1018233 NA CVSA0024R
    69553 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR OTP C.R. BARD, INC. (COVINGTON) -1018233 NA CVSA0024R

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention ALIGN PELVISOFT ACELLULAR COLLAGEN BIOMESH| ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM| WITH HOOK NEEDLE| ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM| WITH HOOK NEEDLE| ALIGN PELVISOFT ACELLULAR COLLAGEN BIOMESH