BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3213451 · Received May 8, 2013

    Report

    Report Number
    1018233-2013-01771
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, 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: 1018233-2013-01772.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202496 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGH0014

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention GYNECARE TVT| AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM