BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3150533 · Received May 24, 2013

    Report

    Report Number
    1018233-2013-01761
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    November 10, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    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: 1018233-2013-01762 AND 1018233-2013-01759.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230602 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL FTL C.R. BARD, INC. (COVINGTON) -1018233 NA ZGI00452

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM | URETEX TO2 URETHRAL SUPPORT SYSTEM