BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3192793 · Received May 2, 2013

    Report

    Report Number
    1018233-2013-01682
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET REC'D. ASSOCIATED MDR: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193602 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGD00204

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| URETEX TO2 URETHRAL SUPPORT SYSTEM