BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3172337 · Received April 18, 2013

    Report

    Report Number
    1018233-2013-01375
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    SOFRADIM PRODUCTIONS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-01374.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168756 TAVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTIONS NA ZGD00675

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TVT| URETEX SUP URETHRAL SUPPORT SYSTEM