BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3172359 · Received May 17, 2013

    Report

    Report Number
    1018233-2013-01372
    Event Type
    Injury
    Date Received
    May 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2013-01371 AND 01373.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219886 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGB00175

    Patients

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