BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS SPARC SLING SYSTEM

    MDR report key: 4090631 · Received September 15, 2014

    Report

    Report Number
    2183959-2014-00403
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 23, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SPARC IMPLANTATION THE PATIENT ¿HAS NOT BEEN ABLE TO VOID.¿ URODYNAMICS WERE PERFORMED AND THE PATIENT HAD TO SELF CATH FOR APPROXIMATELY ONE WEEK DUE TO URETHRAL SWELLING. EVALUATION INDICATED THAT ¿THE URETHRA WAS NOT OVERTIGHT, PATIENT IS ABLE TO URINATE, IT JUST TOOK TIME." THE PATIENT OUTCOME WAS REPORTED AS ¿SHE IS TOTALLY FINE NOW.¿ NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569948 AMS SPARC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention