BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3110979 · Received May 9, 2013

    Report

    Report Number
    2183959-2013-00813
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 23, 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 ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PLAINTIFF WAS IMPLANTED WITH A SPARC SLING ON OR ABOUT (B)(6) 2006 WITH THE INTENTION OF TREATING HER FOR URINARY INCONTINENCE. FOLLOWING THE IMPLANT SURGERY, THE PLAINTIFF HAD TROUBLE URINATING, COULD NOT STAND FOR PROLONGED PERIODS OF TIME, AND SUFFERED PAIN ON AN ONGOING BASIS. SHE SUFFERED FROM NUMEROUS INFECTIONS AND EXPERIENCED PAIN DURING INTERCOURSE. 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
    204953 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC. 428208057

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S