BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3062880 · Received April 12, 2013

    Report

    Report Number
    2183959-2013-00794
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2003, THE PT WAS IMPLANTED WITH A SPARC SLING TO TREAT URINARY INCONTINENCE. IT WAS REPORTED THAT THE PT HAD A PREVIOUS REVISION, DETAILS WERE NOT PROVIDED. ON (B)(6)2013 APPROXIMATELY 2 CM OF MESH WAS REMOVED DUE TO EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159080 SPARC SLING SYSTEM SURGICAL MESH OTN AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention