BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3143003 · Received May 30, 2013

    Report

    Report Number
    2183959-2013-00849
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO 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 THE PLAINTIFF WAS IMPLANTED WITH A SPARC SLING ON OR ABOUT (B)(6) 2004 WITH THE INTENTION OF TREATING HER FOR URINARY INCONTINENCE. FOLLOWING THE IMPLANT SURGERY, THE PLAINTIFF HAD TROUBLE URINATING, COULD NOT LIE DOWN FOR PROLONGED PERIODS OF TIME, AND SUFFERED EXCRUCIATING PAIN IN HER GROIN AND PELVIS. SHE CONTINUES TO SUFFER FROM CHRONIC AND DEBILITATING VAGINA, BACK, LEG AND ABDOMINAL PAIN. SHE HAS SUFFERED FROM RECURRING INFECTIONS AND COULD NOT ENGAGE IN SEXUAL RELATIONS. THE PLAINTIFF EXPERIENCED SIGNIFICANT PHYSICAL, PSYCHOLOGICAL, AND EMOTIONAL PAIN AND SUFFERING, HAS UNDERGONE SURGERIES AND HOSPITALIZATIONS, AND SUSTAINED PERMANENT AND DEBILITATING INJURIES, AS WELL AS CONTINUED PROBLEMS WITH INCONTINENCE. THE PLAINTIFF SUFFERS FROM CHRONIC AND DEBILITATING PAIN, AS WELL AS SIGNIFICANT PSYCHOLOGICAL STRESS AND DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238415 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S