BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    MDR report key: 3315378 · Received August 23, 2013

    Report

    Report Number
    1018233-2013-06794
    Event Type
    Injury
    Date Received
    August 23, 2013
    Report Date
    July 10, 2013
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    FTL
    PMA / PMN Number
    K082571
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATION PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU) WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISK ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4). LAWYER-FILED REPORT - (B)(6).

    Description of Event or Problem · 1

    (B)(4). THIS COMPLAINT IS BEING OPENED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PT'S ATTORNEY IN COMPLAINT NUMBERS (B)(4). THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PT'S OPERATIVE REPORT AND ON THE ACCOMPANYING STICKER PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413346 AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR FTL C.R. BARD, INC. (COVINGTON) NA CVSB0025R

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM-HALO, | AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM -| LOT# HUSD2798, REF#(B)(4)| POSTERIOR, LOT # CVRK0020R, REF# (B)(4)| POSTERIOR, LOT # CVRK0020R, REF# (B)(4)| AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM -| ALIGN TO URETHRAL SUPPORT SYSTEM-HALO,| LOT# HUSD2798, REF#(B)(4)