BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3172200 · Received April 24, 2013

    Report

    Report Number
    1018233-2013-01451
    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
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-01450 AND 1018233-2013-01452.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178242 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZFK00012

    Patients

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