BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA SUPPORT SYSTEM

    MDR report key: 3172275 · Received April 25, 2013

    Report

    Report Number
    1018233-2013-01550
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY HAS ALLEGED THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PERSONAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181057 AVAULTA SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention