BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2823873 · Received October 29, 2012

    Report

    Report Number
    2183959-2012-02887
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    June 27, 2011
    Report Date
    October 5, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION 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 THAT ON OR ABOUT (B)(6) 2006 A SPARC SLING WAS IMPLANTED WITH THE INTENTION OF TREATING URINARY INCONTINENCE. IT WAS ALLEGED BY THE ATTORNEY FOR THE PLAINTIFF THAT AS A RESULT OF THE IMPLANTED MESH THE PLAINTIFF HAS SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME AND CHRONIC PAIN, EROSION OF HER INTERNAL BODILY TISSUE, HARDENING, RECURRENT INCONTINENCE AND REQUIRED ADDITIONAL SURGERY ON 06/27/2011. IT WAS ALSO ALLEGED THAT PLAINTIFF HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS REQUIRED MEDICAL TREATMENT AND HAS SUSTAINED PERMANENT INJURY.

    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