BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3192762 · Received April 26, 2013

    Report

    Report Number
    1018233-2013-01600
    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
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PER ADD'L INFO REC'D, THE PT HAS EXPERIENCED RECTOCELE, ENTEROCELE AND PERINEAL LACERATION. ASSOCIATED MDR: 1018233-2013-01599 AND 1018233-2013-01601.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183452 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention URETEX TO URETHRAL SUPPORT SYSTEM