BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 5381951 · Received January 21, 2016

    Report

    Report Number
    1018233-2012-01056
    Event Type
    Other
    Date Received
    January 21, 2016
    Report Date
    July 31, 2012
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43112 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM