BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3192021 · Received June 20, 2013

    Report

    Report Number
    2183959-2013-00855
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    January 1, 2005
    Report Date
    October 22, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. LAWYER-FILED REPORT - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A SPARC ON (B)(6) 2005 TO TREAT HER BLADDER AND UTERINE PROLAPSE. IT WAS ALLEGED THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING PAIN AND CRAMPING, SCARRING, DYSPAREUNIA, DISCOMFORT, DEPRESSION, ANXIETY AND WAS REQUIRED TO UNDERGO ADDITIONAL MEDICAL PROCEDURES. ON OR ABOUT (B)(6) 2011 THE PLAINTIFF UNDERWENT A PARTIAL MESH REMOVAL. AGAIN ON OR ABOUT (B)(6) 2012, THE PLAINTIFF UNDERWENT ANOTHER MESH REMOVAL PROCEDURE. IT WAS ADDITIONALLY ALLEGED THE PLAINTIFF HAS EXPERIENCED SIGNIFICANT EMOTIONAL, MENTAL AND CHRONIC PHYSICAL PAIN AND SUFFERING, HAS CHRONIC URINARY TRACT INFECTIONS, PROLAPSE, ANAL FISSURES, HAS REQUIRED ADDITIONAL SURGERY AND MEDICAL TREATMENT AND HAS SUSTAINED PERMANENT INJURY AND OTHER DAMAGES. RELATED TO MFR REPORT # 2183959-2012-01473.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281022 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R| S