BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SLING SYSTEM

    MDR report key: 2831761 · Received November 9, 2012

    Report

    Report Number
    2183959-2012-02987
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 16, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT - (B)(4). SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A MINIARC SINGLE SLING ON (B)(6) 2008. IT WAS ALLEGED THE PLAINTIFF SUFFERED AND WILL CONTINUE TO SUFFER PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND AN INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability AVAULTA BIOSYNTHETIC SUPPORT SYSTEM:| LOT NO. CVSF0021| LOT NO. CVSF0021| AVAULTA BIOSYNTHETIC SUPPORT SYSTEM: