BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 5241933 · Received November 22, 2015

    Report

    Report Number
    1018233-2012-02007
    Event Type
    Injury
    Date Received
    November 22, 2015
    Report Date
    November 2, 2015
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772267 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM Mesh, surgical, polymeric FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention ALIGN TO URETHRAL SUPPORT SYSTEM | AVAULTA PLUS ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PELVISOFT ACELLULAR COLLAGEN BIOMESH