BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 3910038 · Received June 11, 2014

    Report

    Report Number
    2183959-2014-12310
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    September 1, 2012
    Report Date
    July 2, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    PMA / PMN Number
    K011251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PLAINTIFF'S ATTORNEY THAT THE PLAINTIFF ALLEGEDLY EXPERIENCED PAIN, INFECTION, BOWEL PROBLEMS, ORGAN PERFORATION, VAGINAL SCARRING, EMOTIONAL DISTRESS AND A PRODUCT PROBLEM. IT WAS ADDITIONALLY REPORTED THAT THE PLAINTIFF HAD THE MESH REVISED AND ANOTHER MANUFACTURERS MESH WAS IMPLANTED ON (B)(6) 2013 DUE TO RECURRENT STAGE 2 CYSTOCELE, RECURRENT STRESS URINARY INCONTINENCE, URGENCY, DIFFICULTY URINATING, VAGINAL PROTRUSION, VAGINAL IRRITATION, AND URETHRAL INJURY. FURTHERMORE, IT WAS REPORTED THAT THE PLAINTIFF DIED. NO CAUSE OF DEATH WAS REPORTED. RELATED TO MANUFACTURER REPORT #2183959-2014-12309.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PLAINTIFF EXPERIENCED VOIDING DIFFICULTY AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346328 AMS SPARC SLING SYSTEM MESH, SURGICAL POLYMERIC OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death GYNECARE TVT