BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2842103 · Received November 13, 2012

    Report

    Report Number
    2183959-2012-02997
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    March 1, 2008
    Report Date
    October 25, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. (B)(4).

    Description of Event or Problem · 1

    RELATED TO MFR REPORT # 2183959-2012-02998. IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF WAS IMPLANTED WITH A SPARC SYSTEM ON OR ABOUT (B)(6) 2008, TO TREAT STRESS URINARY INCONTINENCE AND CYSTOCELE. IN (B)(6) 2008, THE PLAINTIFF BEGAN EXPERIENCING RIGHT SUPERPUBIC PAIN, VAGINAL DISCOMFORT WITH ACTIVITY AND VAGINAL PAIN WITH PROLONGED SITTING. THE PLAINTIFF WAS TREATED WITH VAGINAL CREAM. AFTER WEEKS OF THERAPY, THERE WERE NO SIGNS OF IMPROVEMENT, SO THE PLAINTIFF SOUGHT FURTHER MEDICAL CONSULTATION. ON (B)(6) 2008, THE PLAINTIFF WAS HOSPITALIZED AND TREATED FOR A SEVERE URINARY TRACT INFECTION. ON (B)(6) 2009, DOCTORS PERFORMED A CYSTOURETHROSCOPY AND DIAGNOSED THE PLAINTIFF WITH BLOOD PER HER VAGINA AND GROSS HEMATURIA OF AN UNCLEAR ETIOLOGY. IN (B)(6) 2010, THE PLAINTIFF OBTAINED FURTHER MEDICAL CONSULTATION FOR EXCRUCIATING HIP AND PELVIC PAIN. IN (B)(6) 2010, THE PLAINTIFF WAS AGAIN DIAGNOSED WITH HEMATURIA. A COMPUTERIZED AXIAL TOMOGRAPHY SCAN OF THE ABDOMEN AND PELVIS WAS ORDERED IN AN ATTEMPT TO DETERMINE THE CAUSE OF THE PLAINTIFF'S CHRONIC HEMATURIA AND BOWEL CHANGES. IN (B)(6) 2011, THE PLAINTIFF WAS HOSPITALIZED AND DIAGNOSED WITH GROSS HEMATURIA OF AN UNCLEAR ETIOLOGY. IN (B)(6) 2012, THE PLAINTIFF WAS TREATED FOR HEMATURIA, CONSTIPATION, BOWEL CHANGES, AND ABDOMINAL PAIN. PLAINTIFF'S TREATMENT IS STILL ONGOING AND HER MEDICAL ISSUES HAVE NOT BEEN RESOLVED.

    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 PERIGEE | PERIGEE