BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3172221 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01466
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01467, 1018233-2013-01468, AND 1018233-2013-01469.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178251 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGG00688

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention PELVISOFT ACELLULAR COLLAGEN BIOMESH| GYNECARE TVT SYSTEM| AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM| PELVISOFT ACELLULAR COLLAGEN BIOMESH