BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3192700 · Received April 26, 2013

    Report

    Report Number
    1018233-2013-01610
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    March 29, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01598.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183454 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGC00002

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention GYNECARE TVT SECUR SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM