BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3133012 · Received May 16, 2013

    Report

    Report Number
    2183959-2013-00830
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    November 4, 2004
    Report Date
    April 30, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT-(B)(4). 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 BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A SPARC SLING SYSTEM ON OR ABOUT ON (B)(6) 2004, FOR THE PURPOSES OF TREATING HER FOR STRESS URINARY INCONTINENCE. IT WAS ALLEGED THE PLAINTIFF IMMEDIATELY SUFFERED PAIN THAT EXTENDED FROM HER NAVEL DOWN TO THE INSIDE OF HER LEGS, CHRONIC AND DEBILITATING VAGINAL, BACK, AND ABDOMINAL PAIN, HAS HAD TROUBLE URINATING, CANNOT SIT OR STAND FOR PROLONGED PERIODS OF TIME, PELVIC PAIN ON AN ONGOING BASIS, RECURRENT YEAST AND BLADDER INFECTIONS, CONTINUED INCONTINENCE, AND VAGINAL ODOR. THE PLAINTIFF HAS EXPERIENCED SIGNIFICANT PHYSICAL, PSYCHOLOGICAL STRESS, DEPRESSION AND EMOTIONAL PAIN AND SUFFERING, HAS UNDERGONE SURGERIES AND HOSPITALIZATION AND SUSTAINED PERMANENT AND DEBILITATING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219042 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S