BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3192022 · Received June 20, 2013

    Report

    Report Number
    2183959-2013-00873
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    December 1, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ON OR ABOUT (B)(6) 2008 THAT THE PLAINTIFF WAS IMPLANTED A SPARC PELVIC MESH PRODUCT WITH THE INTENTION OF TREATING THE PLAINTIFF FOR PELVIC ORGAN PROLAPSE. IT WAS ALLEGED THE PLAINTIFF SUFFERED SERIOUS BODILY INJURIES, INCLUDING, BUT NOT LIMITED TO, EXTREME AND CHRONIC PAIN, EROSION OF MESH AND INTERNAL BODILY TISSUE, HARDENING, WORSENING DYSPAREUNIA, RECURRENT INCONTINENCE, ADDITIONAL SURGERY AND OTHER INJURIES. THE PLAINTIFF HAS ALSO EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, MEDICAL TREATMENT, AND SEVERE PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281251 SPARC SLING SYSTEM SURGICAL MESH OTM AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S