BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2770374 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02789
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    March 28, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PLAINTIFF HAS A CONDITION THAT REQUIRED SURGICAL INTERVENTION FOR REPAIR. PLAINTIFF WAS IMPLANTED WITH THE AMS SPARC SYNTHETIC MESH SYSTEM ON (B)(6) 2005." IT WAS ALLEGED BY THE PLAINTIFF'S ATTORNEY THAT, "WITHIN MONTHS AFTER THE INITIAL IMPLANT PROCEDURE, PLAINTIFF EXPERIENCED COMPLICATIONS" AND REQUIRED, "ADDITIONAL MEDICAL CARE AND TREATMENT AND/OR SURGICAL INTERVENTION." IT WAS ALSO ALLEGED, "AS A RESULT OF THE SUBJECT SYNTHETIC MESH SYSTEM, PLAINTIFF SUFFERED DEBILITATING INJURIES FROM THE SYNTHETIC MESH INCLUDING MESH EROSION, HARDENING, CHRONIC PAIN AND WORSENING URINATION LEADING TO THE NEED FOR DANGEROUS AND SERIOUS SURGERY," AND "HAS SUFFERED AND WILL CONTINUE TO SUFFER MENTAL ANGUISH, DIMINISHED CAPACITY FOR THE ENJOYMENT OF LIFE, A DIMINISHED QUALITY OF LIFE, CHRONIC DEBILITATING PAIN, AND OTHER SUCH DAMAGES."

    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