BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2871395 · Received December 5, 2012

    Report

    Report Number
    2183959-2012-03094
    Event Type
    Injury
    Date Received
    December 5, 2012
    Report Date
    November 1, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT-(B)(4). SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U 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 SPARC SELF-FIXATING SLING SYSTEM ON OR ABOUT (B)(6) 2008 TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. IT WAS ALLEGED THE PLAINTIFF EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, SEVERE EMOTIONAL DISTRESS, ANGUISH, ANXIETY, PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, IRREPARABLE BODILY INJURY, HAS UNDERGONE AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S