BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3250028 · Received July 24, 2013

    Report

    Report Number
    1018233-2013-02969
    Event Type
    Injury
    Date Received
    July 24, 2013
    Report Date
    October 12, 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
    FL, 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

    COMPLAINT # (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDRS: 1018233-2013-02970 AND 02971.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346082 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR No Match OTP C.R. BARD, INC. (COVINGTON) NA CVRH0021
    346083 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR No Match OTP C.R. BARD, INC. (COVINGTON) NA CVRH0021

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM: | LOT# 05B33-2| PELVISOFT COLLAGEN BIOMESH PROD# 481047,| PRODUCT# BRD400HK, LOT# CVRJ0018| LOT# 05B33-2| ALIGN TO URETHRAL SUPPORT SYSTEM:| PRODUCT# BRD400HK, LOT# CVRJ0018| PELVISOFT COLLAGEN BIOMESH PROD# 481047,