BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3213441 · Received May 30, 2013

    Report

    Report Number
    1018233-2013-02243
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, SUFFERING, DISABILITY AND IMPAIRMENT. ASSOCIATED MDR: 1018233-2013-02241.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239802 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGD00697

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC OBTRYX TRANSOBTURATOR| MID-URETHRAL SLING SYSTEM