BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARC SLING SYSTEM

    MDR report key: 3010318 · Received March 12, 2013

    Report

    Report Number
    2183959-2013-00748
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPARC SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE FOR TREATMENT. INFORMATION RECEIVED INDICATES URETHRAL OBSTRUCTION AND URETHRAL TEAR ON (B)(6) 2013 AND SUBSEQUENTLY THE PATIENT UNDERWENT EXCISION OF MESH AND URETHRAL REPAIR ON THE SAME DATE. THE PATIENT IS "SATISFACTORY AT THIS POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104341 SPARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S