BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 2922098 · Received January 4, 2013

    Report

    Report Number
    2183959-2013-00044
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    January 1, 2011
    Report Date
    December 19, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPARC SLING WAS IMPLANTED IN 2009. IN 2011-2012 SCAR TISSUE DEVELOPED AROUND THE SLING THAT CAUSED DIFFICULTY URINATING. THE PATIENT WAS TREATED WITH MEDICATION REPAFLO AND WITH SURGERY TO REMOVE THE SPARC, REPORTED TO HAVE SCAR TISSUE ATTACHED ON REMOVAL. THE PATIENT CONTINUES TO HAVE PROBLEMS URINATING AND HAS URETHRAL SPASMS. ALSO REPORTED, STRAINING TO URINATE CAUSED HEMORRHOIDS, SCHEDULED TO BE REMOVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5326 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S